Quality Operations Resume Sample

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Laverna Schulist
633 Kautzer Terrace,  Boston, MA
+1 (555) 435 2895

Work Experience

Quality Operations Manager
01/2016 - PRESENT
Philadelphia, PA
  • Engage with the Regional Finance DQ team, Finance, Chief Data Office (CDO) contacts in the analysis of DQ indicators (e.g., adjustments, regulatory/audit comments, process re-engineering reviews, and other sources) and subject those that qualify as issues to Citi’s Issue Management & Resolution (IMR) process
  • Collaborate with other regions’ FRO DQ teams in addressing common issues and adopting best practices
  • Fluent in English. An additional European language is an asset
  • Analyzes plant reports for significant quality trends and report’s conclusions
  • Support and approve validations as required
  • Leads and directs Quality Assurance departments, manages the development and performance of assigned staff. Ensures the department's objectives and accomplishments meet the organization's goals and strategic plan
  • Drives the development and deployment of innovative global policies, requirements, and strategies for quality systems
  • Provides leadership in establishing systems to support the QA vision
Quality Operations Engineer
10/2008 - 09/2015
Chicago, IL
  • Monitor operations across the spectrum of the Thule BMC, analyze current process and procedures, metrics and assist with a strategy for improving if necessary
  • Developmental Lead for Man Hour Utilization with the intent to improve overall quality
  • Promotes quality culture and policies by training the workforce in quality principles and objectives
  • Interfaces with customers and suppliers to facilitate corrective action responses and reports. Makes presentations or attend customer meetings regarding Quality Performance
  • Maintains and oversees operational performance metrics
  • Liaison with other team members, including interacting with managers of different areas of the organization, presenting findings to stakeholders and higher management
  • Oversees internal and external audits. Spearheads corrective actions
Technical Assistant Quality Operations Befristet für Monate
12/2005 - 06/2008
Houston, TX
  • Ensures resources are available to assure product/process/service quality
  • Interfaces with Regulatory personnel during government or corporate audits
  • Identifying and implementing value improvement projects (VIP’s)
  • Facilitating and assisting in GMP, ISO and other internal/external audits and investigations pertaining to Baxter facilities, where applicable
  • Ensure the smooth implementation and operation of the Batch Release process in Solothurn (also acting as the RP o deputy RP)
  • Once operational, serve as the main point of contact for Batch Release, Deviation and CAPA Management, Annual Product Reviews, Change Control (product related) processes at Solothurn
  • Maintains the Quality Program Plan (QPP) and Quality Status Report (QSR) quality program that meets the standards of the Performance Work Statement (PWS), AFI’s and all applicable Thule Air Base Instructions (TABI)


Mayville State University
2001 - 2005
Bachelor's Degree in Science

Professional Skills

  • Strong tactical planning and execution abilities, including strong organization skills is required
  • Has experience in writing and review / approval of protocols/validations and has proven knowledge of validation principles
  • Strong writing skills to effectively communicate technical/clinical information to others
  • Demonstrated strong financial/analytical skills
  • Excellent technical and compliance-based writing skills
  • ASQ certification as Certified Quality Engineer or demonstrated advanced lean manufacturing skills
  • Strong persuasive and influencing skills, but also a good team player

How to write Quality Operations Resume

Quality Operations role is responsible for organization, leadership, advanced, interpersonal, english, manufacturing, planning, intermediate, communications, organizational.
To write great resume for quality operations job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Quality Operations Resume

The section contact information is important in your quality operations resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:

  • First and last name
  • Email
  • Telephone number

Work Experience in Your Quality Operations Resume

The section work experience is an essential part of your quality operations resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous quality operations responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular quality operations position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Quality Operations resume experience can include:

  • Solid experience with effectively managing FDA and other regulatory inspections, working with regulators, and vendor audits is essential
  • Appropriately prioritizes team goals and individual goals to effectively achieve business objectives
  • Effectively partner with Operations Managers and Supervisors to develop and implement strategies which promote the Terumo Quality Culture throughout operations
  • Demonstrated experience in blueprint reading/interpretation, including a thorough understanding of GD&T
  • Demonstrated experience in Quality Engineering, Quality Systems/Compliance
  • Places a strong emphasis on effective communication. Meets regularly with the immediate work group, Manager, and customers being supported

Education on a Quality Operations Resume

Make sure to make education a priority on your quality operations resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality operations experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.

Additional details to include:

  • School you graduated from
  • Major/ minor
  • Year of graduation
  • Location of school

These are the four additional pieces of information you should mention when listing your education on your resume.

Professional Skills in Quality Operations Resume

When listing skills on your quality operations resume, remember always to be honest about your level of ability. Include the Skills section after experience.

Present the most important skills in your resume, there's a list of typical quality operations skills:

  • Strong strategic planning and tactical execution abilities, including strong organization skills is required
  • Prior experience effectively working through periods of change, ambiguity and complexity is required
  • Strong project management skills, innovative abilities and strong drive to improve (preferably Green Belt certification)
  • Strong Analytical skills, MS Excel – good to intermediate
  • Good planning and scheduling skills
  • Good computer skills, including proficiency with business and technical software (Word, Access, Excel, Powerpoint)

List of Typical Experience For a Quality Operations Resume


Experience For Quality Operations Manager Resume

  • Assist in assessing work schedules to achieve the greatest efficiencies and effectiveness
  • Support the development of efficient and effective methods for meeting Quality System requirements
  • Manage Quality Assurance inspection staff and processes related to incoming inspection and release of finished goods
  • Three years of related database management experience
  • Executing In Process Testing and Sampling activities (per instructions and procedures approved by Quality Control)
  • Planning and controlling change

Experience For Manager, Quality Operations Resume

  • Managing the Quality oversight over the manufacturing operations (“on the floor”) (includes warehouse operations)
  • Approving investigations following deviations and related CAPAs
  • Assuming the role as senior company representative at the work site (Thule AB, Greenland)
  • Managing quality assurance programs
  • Researching new technologies and alternative methods of efficiency
  • Establish a culture that makes developing, manufacturing and distributing products with industry leading quality and reliability a core competency
  • Help QA improve process including planning, estimation, problem solving, and scheduling
  • Responsible for hiring, coaching, and counseling employees, including performance reviews, disciplinary action, and terminations

Experience For Director, Quality Operations Resume

  • Carries out leading responsibilities in accordance with the organization’s policies and applicable laws including regarding health and safety
  • Define programs for reviewing, testing and refurbishing returns to maximize returns put back into prime when economically feasible
  • Provides coaching and mentoring of manufacturing supervisors and operators
  • Provide system administration functions for Quality Connect, including user maintenance, training, corporate sign-off and reporting (AI/QOC/PRRT modules)
  • Composes and presents monthly summary reports to management summarizing activities, including trending and graphic representations
  • Establish and maintain training development and execution of JJMD quality personnel per-forming lot release certification and monitoring activities

Experience For Quality Operations Specialist Resume

  • Comprehensive understanding of auditing principles. Broad knowledge of manufacturing processes
  • Track record of meeting business goals via driving disciplined, fact-based decision and executing with discipline and urgency
  • Product Launch Summary – sharing learning’s
  • Oversee the packaging and shipping process, and authorize shipment
  • Oversees, Quality Operations/Assurance Shift Managers to ensure assessment and development of talent and ongoing coaching to ensure successful performance
  • Ensure that Quality Processes (documented & implemented) are in place on the manufacturing & packing areas
  • Research and review new tools and solutions, including setting up POCs and implementation
  • Assist QA Teams with outsourcing and developing best practices

Experience For Senior Quality Operations Manager Resume

  • Drive the development of appropriate documentation, training, labeling and quality systems for UT
  • Provides Quality leadership in the development/implementation of Standard Operating Procedures (SOPs)
  • Ensure transfers to manufacturing are data driven and robustly executed
  • Support activities associated with environmental controls and monitoring
  • Responsible for the entire value chain of the product within Illumina’s manufacturing operations
  • Continuous improvement leadership applying the elements of lean/operational excellence

Experience For Manager Quality Operations Resume

  • Assists in gathering data or documentation to support team’s analysis or audit reviews
  • Ensure that the Operations Team is following GMP’s
  • Coordinates and assists inspection and engineering personnel as needed
  • As part of the senior management team, develops the appropriate plans to support and meet the Corporate, Franchise and Region operating objectives
  • Interfaces with other functions to analyze data and provide solutions for quality issues

Experience For Quality Operations Associate Manager Resume

  • Implements a Risk Management Plan associated with the aforementioned activities. Develops, maintains, and reports performance metrics which effectively measure the level of performance in execution of the PWS and additional projects
  • Establish and promote a work environment that supports compliance with the TMC Quality System and Terumo’s policies
  • Prepare, communicate, and evaluate team goals and objectives for continual improvement of the quality system. Ensure linkage to Strategic Quality Plan
  • Manage a team of Quality Engineers in driving robust problem solving, NC reduction and continual improvement efforts. Drive values stream optimization through the application of proven methodologies such as Six Sigma, LEAN, Kaizen events etc
  • Promote production line value stream characterization and optimization efforts. Ensure process control plans (SPC, sampling, inspection methods) are appropriate and effective
  • Ensure operations related CAPA activities are managed in a complete and timely manner
  • Partner with internal support functions (i.e. laboratory operations, calibration & metrology, supplier control, distribution etc.) to achieve functional excellence
  • Manage Quality Control staff activities
  • Prepare for, and support compliance audit activities in Operations

Experience For Quality Operations Engineer Resume

  • Maintain Quality Performance Indicators in support of management oversight activities
  • Support the preparation and conduct of compliance forums such as Quality System Management Reviews, Change Board Meetings, NC/CAPA Board meetings etc
  • Promote the professional growth and development of staff personnel
  • Knowledge of national and international regulations applicable to medical devices including; Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDR etc., LEAN
  • Identify the strategic direction of the quality assurance system required
  • Analyze and interpret all regulatory and quality guidelines as needed
  • Demonstrate a strong understanding and working knowledge of the Quality Sciences (Acceptance Sampling, SPC, continual improvement, Six Sigma, LEAN, Design of Experiments, COQ, Cause & Effect analysis etc.)
  • Responsible for designing and supporting all related databases and reporting tools.
  • Extracts and interprets operations data for reporting to hospital leadership, medical staff, board and others as requested.

Experience For Quality Operations Analyst Resume

  • Analyzes all data for benchmark program and productivity reporting and prepares and analysis reports.
  • Promotes a team environment, willing to assist others, and responds timely to all information requests.
  • Participates in strategic planning and quality improvement for the organization.
  • Supports the asset team in product lifecycle management initiatives including change control, regulatory submissions and subsequent market launch
  • Completes timely data analysis and presentation and makes recommendations on decisions based on that analysis.
  • Completes regular reports as requested.
  • Maintains confidentiality for all patient and organizational information.

Experience For Senior Manager Quality Operations Resume

  • 1) Strategy development and implementation
  • 4) Change Control Management
  • Maintain the quality system and the quality culture and aim for continuous improvement
  • Make independent quality decisions
  • Fulfill the notification requirements for quality defects to the Board of Health in Poland
  • Lead the preparation and coordination of GMP/GDP inspections
  • Ensure quality oversight of the contractors in the GDP/GMP area
  • Supports and manages Quality aspects of commercial product life cycle management by facilitating the execution of Quality activities in collaboration with the Asset team and Quality line functions. Ensures effective communication with the Asset lead and Global Quality Management
  • Through project management and leading the quality sub teams ensures Quality activities are planned for and completed to meet Asset milestones

List of Typical Skills For a Quality Operations Resume


Skills For Quality Operations Manager Resume

  • Demonstrated and potential leadership skills including strong communication and risk assessment
  • Demonstrated ability to lead, communicate, interact and influence effectively at technical and management levels across functions
  • Time management skills, able to manage multiple projects and priorities
  • Strong written and oral communication skills in English and preferably in Dutch
  • Excellent verbal & written communication skills (internal & external customers)
  • Effective leadership skills and ability to influence department and peers, as well as be a team player

Skills For Manager, Quality Operations Resume

  • Outstanding management and communication skills
  • Strong working knowledge of TPM, OEE and Lean and the ability to utilize these tools to create and operate a high performing organization
  • Proven Supervisor or Management experience leading others
  • Effectively deal and negotiate with representatives of various governmental agencies and auditing agencies
  • Proven experience in leading others with a proactive attitude
  • Scientific literature searching and evaluation skills
  • Experience in Medical Device industry and knowledge of Good Manufacturing Practices
  • Prior experience working in a highly matrixed organization0645170510
  • Organizational and operational agility, able to operate at all levels of the organization and able to shift priorities successfully

Skills For Director, Quality Operations Resume

  • Reviewing/Approving sub-contractor's validation protocols, Master Documents and significant deviations and investigations
  • Manufacturing experience/QA Operations in a GMP Environment
  • Demonstrated success in growing and coaching high performing engineering teams and leading change for product quality
  • Experience productively interfacing with marketing, business development, engineering, manufacturing, quality, and regulatory functions
  • Experience in team management, including hiring, building key projects and career management
  • Experience setting up, managing and interpreting databases
  • Good understanding of online marketing terms

Skills For Quality Operations Specialist Resume

  • Experience taking initiative with innovative ways to problem solve in a fast-paced, changing business environment is required
  • Experience initiating and driving projects to completion with minimal guidance
  • Assists in development of roles and responsibilities for new QAOTF organization supporting Oral Solid Dose (OSD) manufacturing operations
  • Experience using the Web for research conducting purposes
  • Experience in auditing techniques, interpreting regulations and quality system helpful
  • Accountable for ensuring full quality and regulatory compliance of a facility, while driving process effectiveness and efficiency at the site
  • Relevant experience working in manufacturing/operations
  • Self-motivated and self-managing. Able to identify, execute and prioritize work tasks/projects with an awareness of escalation responsibility as needed
  • Managerial experience working within an FDA and ISO 13485 regulated industry.Quality Assurance

Skills For Senior Quality Operations Manager Resume

  • Experience in data quality and / or testing and / or data analysis
  • Strong decision making ability is desired; Positive attitude - morale booster
  • Good business acumen and understanding that Operations and Quality are a critical part of a business enterprise
  • Strong decision making ability is desired
  • Experience in Project Management; Risk Management; Budget management; Quality Auditing; Operations Processes; Systems Development & Integration are required
  • Preferably experienced and knowledgeable to translate appropriate business processes into accurate Standard Operating Procedures or Quality Systems
  • Experience in Quality Engineering or equivalent in the medical device or pharmaceutical industry
  • Able to adjust workload based upon changing priorities
  • Experience interacting with regulatory agencies such as the FDA and EU regulatory bodies as an inspection host

Skills For Manager Quality Operations Resume

  • Good understanding of Inspection (GD&T), Metrology, PMC, and GMP
  • Experience with data entry and use of data tracking systems
  • Experience in Quality, Engineering or related field
  • Experience in virology testing methods
  • Experience in a GMP manufacturing environment

Skills For Quality Operations Associate Manager Resume

  • Successful progressively responsible experience related to pharmaceutical and medical device manufacturing
  • Experience working in both an FDA and European regulatory environment
  • Use and learn tools like SQL and Excel to drive analytic and reporting is a strong preference
  • Experience in quality assurance field in a medical device manufacturing environment
  • Work with clients of diverse incumbent skill base
  • Relevant experience

Skills For Quality Operations Engineer Resume

  • Experience as a functional (people) manager
  • Experience in FDA regulated Medical Device industry with design transfer management responsibility
  • Intermediate ASP (application service provider), SQL & VBA (Visual Basic for Applications), experience, hardware knowledge
  • Good business acumen and understands that Operations and Quality are a critical part of a business enterprise
  • Plan and prioritize activities as well as ability to work independently to meet assigned project deadlines
  • Skilled at Microsoft Word, PowerPoint and other presentation software
  • Printed Circuit Board Assembly experience
  • Certification as a Level III radiographer with experience in testing and inspection of aircraft components; weldments, and composite fabricated parts

Skills For Quality Operations Analyst Resume

  • Review, validate, and implement requests for new and updated materials per the data standards
  • Demonstrated ability to train, manage and coach staff
  • Participating with subcontractors to find solutions concerning quality issues
  • Responding to customer complaints, including close out and determination of corrective actions
  • Working knowledge and ability to apply GMP's in conformance to US, EU and ROW standards

Skills For Senior Manager Quality Operations Resume

  • Ensuring the quality of materials purchased, processed, manufactured and distributed by the organization throughout the assembly facilities
  • Working knowledge of quality tools: measurement repeatability systems, process control tools (Statistical Process Control)
  • Working knowledge of Lean / Six Sigma
  • Working with the supplier and operations directly, to address corrective actions (SCAR’s) and MRR’s as required
  • Assisting in implementation and enhancement of Sanofi IT systems
  • Achieving of Key Performance Indicators on the Plant Scorecard related to safety, quality, production and customer service levels

List of Typical Responsibilities For a Quality Operations Resume


Responsibilities For Quality Operations Manager Resume

  • Provide guidance and procedures to CSI Return inspectors/processors to maximize returns put back into prime stock, thus reducing seconds and destroys, while maintaining FG/GR high quality standards for prime product
  • Ensure adequate reboxing processes to properly protect and display product put back into prime, including provision of original packaging when quantities are sufficient, to minimize/eliminate perceptions that product is used or second quality
  • Trains, motivates and coaches the Quality team members on the essential skills needed so that each of them has the tools they need to succeed at their job
  • Manage and effectively lead quality engineers, lab supervisors and other quality team members as deemed necessary
  • Collaborates and cooperates with other functional areas including; Human Resources, Training, Workforce, Marketing, Risk, Fleet & Merchant teams
  • Can remain calm and operates efficiently when dealing with high-pressure situations, combative discussions and grey areas

Responsibilities For Manager, Quality Operations Resume

  • Follows directives of Director of Customer Experience & Training or Sr. Site Director
  • Medical device manufacturing experience is required
  • Able to demonstrate a clear vision, global mind-set and successful people and culture leadership
  • Demonstrated ability to train, manage, and coach staff
  • Maintains an excellent working knowledge of the entire Support - Quality operation, as well as developing Quality processes
  • Manages changing priorities in a multi-tasked environment
  • Provide appropriate technical input and review of design control and validation activities is required
  • Working knowledge and ability to apply GMP in conformance to U.S., EU, and ROW standards

Responsibilities For Director, Quality Operations Resume

  • Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
  • Comfortable pulling in cross functional experts, when appropriate, to resolve issues swiftly while putting the integrity of Facebook's Audience Network first
  • Ensures appropriate maintenance of lab facilities by issuing and following up on work orders
  • Provide feedback regarding areas of opportunity and trending reports
  • Interpret and enforce Facebook's Audience Network policies including our community standards
  • Broad understanding of Audience Network policies and community standards

Responsibilities For Quality Operations Specialist Resume

  • Serves as a subject matter expert providing guidance,
  • Managing a large non-exempt team of direct reports
  • Recruitment, supervision, training and development of all QA personnel, approximately 60 QA associates
  • Develop and implement audit processes to ensure all buildings achieve maximum returns to prime at acceptable quality levels
  • Liaison with CSI Customer Service and Inventory Planning to stock and fulfill parts when feasible to reduce returns and improve customer satisfaction. Monitor parts levels to ensure adequate but not excessive stock on hand
  • Ensure adequate recovery of return dollars for P&H, out of warranty, customer damages or freight damages
  • Experience in related Clinical and Commercial Quality leadership covering related GMP and Clinical quality assurance in both tactical and strategic capacities
  • As a senior Quality representative for the company responsibilities include being the primary interface with business and system related issues at contract manufacturing and laboratory organizations (CMO’s). The interface is coordination with senior representatives of supply chain operations
  • Develop the procedures and systems required by cGMPs, FDA Regulations/Guidance’s and Ironwood’s Policies, to monitor and control the quality of the drug substances and products

Responsibilities For Senior Quality Operations Manager Resume

  • Conducts CAP investigations and analyses of primarily moderate complexity
  • Broad generalist profile with cross-functional background would be valuable
  • Able to envision and implement innovative processes across multiple support functions with available technologies
  • Be the voice of the advertiser and advocate for Publisher Quality across Audience Network
  • Implement best-in-class escalations processes and practices for improving quality of publishers and publisher traffic on Audience Network including best practices for sales and operations teams
  • Use sound judgment, specific knowledge, signals and insights to drive scaled solutions to support Audience Network partners
  • Develop strong cross-functional partnerships with partnerships, policy, legal, engineering, data science, sales, product management and other teams at Facebook in order to implement optimal solutions to quality related issues

Responsibilities For Manager Quality Operations Resume

  • Build and iterate on policy enforcement practices
  • Leads CAP investigations and analyses in gas operations
  • Directly supervises QA Supervisors, Quality Engineers, and non-exempt associates, Participates in the interview and selection of qualified employees for authorized job openings
  • Comfortable pulling in cross-functional experts, when appropriate, to resolve issues swiftly while putting the integrity of Facebook's Audience Network first
  • Serve as the leader for Illumina’s global manufacturing groups in the production of medical reagents, instruments and consumable products
  • Integrate quality systems with Illumina’s enterprise management systems and shop floor management execution system

Responsibilities For Quality Operations Associate Manager Resume

  • Build the world’s best team to guide Illumina to become the clear front runner in the delivery of high quality products and services
  • Familiarity with shop floor and desk top software such as MS Office, MES, LIMS, eTQ
  • Check Bids, Offers and Trades (BOTE’s) for Singapore, London and Houston Oil and Shipping Benchmark assessments daily, informing price reporters of errors
  • Be the ‘go to’ resource with the offshore team in Mumbai (GAC – Crisil) working to resolve raised queries and close out the escalation log findings
  • Responsible to detect and implement Quality Trainings to the Operations team (i.e. Control Plans, GMP’s, etc)
  • Proficiency in the use of personal computers and computer database software, including Microsoft Office applications (Access, Excel, Word and PowerPoint). Visio and Project knowledge desirable

Responsibilities For Quality Operations Engineer Resume

  • Ensure that the organisation’s conformance and commitment to producing products meets or exceeds customer requirements and the relevant regulatory standards
  • Coordinate and conduct routine and directed audits as needed to assure compliance with domestic and international regulations, local SOP’s and corporate standards.[i.e. QMS , QSIT, Combination Products, Regulatory requirements; Notified Bodies, etc]
  • Critically analyze, using appropriate sources of data, Smiths Medical operations capabilities; setting strategy, structure, and processes to drive sustained quality improvement in local manufacturing facility
  • Develop world class, common systems for completely integrating Quality Management Systems with Operational processes and the Smiths Operating System. Develop key metrics and scorecards to measure quality level performance within the manufacturing facility
  • Align site and quality objectives with the Business Plan, Operations Objectives, and the Global Manufacturing Quality System to assure effective and efficient use of resources and manufacturing quality excellence
  • Set facility level Quality operations goals and objectives for customer focused quality initiatives. In particular analyze customer complaint trend data and set strategies, structure and processes to drive improvements in operations quality
  • Collaborate with NPI teams to ensure that quality attributes, manufacturability and lessons learned from existing products (e.g. production performance, quality problems, complaints) are integrated into the design and manufacturing processes
  • Operates and coordinates the Fluoroscope X-ray Laboratory
  • Develops and writes NDI procedures

Responsibilities For Quality Operations Analyst Resume

  • Develops and fabricates NDI standards for various advanced materials
  • Coordinates Fluoroscope/X-ray inspections of various advanced composite components, rotor blade assemblies or weldments
  • Managing the Batch release process (includes being the point of contact for other Quality functions within the Biogen network regarding the release and distribution of manufactured batches)
  • Act as the main point of contact with the Corporate Product Quality Manager for Change Control (product related), Annual Product Reviews, and Process Validation topics
  • Manage, maintain, and further enhance Quality Assurance Operations as related to product quality and overall compliance within the context of a virtual sponsor/business partner environment. These responsibilities include but are not limited to

Responsibilities For Senior Manager Quality Operations Resume

  • Plans, evaluates and facilitates broad Quality Assurance programs to ensure current Good Manufacturing Practice compliance and company preparedness for FDA inspections
  • Responsible for the direct supervision and development of individuals within the Quality Operations group. Assures documents and systems are maintained according to company policies and procedures
  • Responsible for the review and approval of internal documents including standard operating procedures, batch records, logbooks, and other associated batch-related documentation. Assures documents are maintained according to company policies and procedures
  • Openly collaborates with Operations in daily compliance functions. Provides QA position, advice, and assistance when a non-compliance" situation occurs
  • Facilitates, reviews and approves the effective investigation and root cause analysis of manufacturing and packaging Exceptions and supports timely corrective/preventive action

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