Quality / Control Associate Resume Sample
Dallas Langworth
337 Cindy Drive,
Houston,
TX
+1 (555) 466 2735
Work Experience
Purchasing / Quality Control Associate
02/2018
-
PRESENT
Dallas, TX
- Lead self-inspections across Confirmations and CTR units for varied activities, including
- Project support and management (time management, exhibits initiative in collaborative problem solving)
- Ensure proper escalation, vetting and approval of Negative Media and AML/Sanctions Alerts
- Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results
- Provides timely review for data and documentation generated for or by QC
- Issues testing CoA’s and releases raw materials
- Experience with ISO 13485 certification and federal regulations 21 CFR 820 and 21 CFR Part 11
- Experience in a Good Manufacturing Practice (GMP) environment
Member Services Quality Control Associate
02/2011
-
11/2017
San Francisco, CA
- O Performs, as assigned, in-process and final product sterility testing of Dendreon products (e.g., sterility by BacT/Alert)
- Ensure that all activities are performed according to the local Quality System and SOP’s, as well as national and local regulations
- Demonstrate behaviors and positive attitudes in line with QC values
- Participates in or leads investigations of laboratory deviations and investigations
- Participate in QC process improvement projects
- Work in a team environment to manage and coordinate analytical and stability activities between contract testing labs and CMOs
- Serve as an SME and oversee method transfer and method validation at contract testing labs
- Develop QC policies
Operations Associate Iv-commercial Lending Quality Control
06/2008
-
08/2010
Boston, MA
- Participate in regulatory filings and contribute to appropriate sections of regulatory documents
- Participate in cGMP audits of contract testing labs
- Establish and review quality control documents (e.g. SOPs, Change Controls, deviations, raw data etc), protocols, reports, procedures and certificates
- Evaluate, review and trend quality control data for clinical products
- Work with manufacturing on retains programs
- Be a key member of the interdisciplinary development project teams
- Manage and coordinate effectively quality control deliverables and milestones for analytical projects and ensure successful and timely completion
- Promote a culture of high quality standards
Education
University of Wisconsin-Richland
2002 - 2007
Bachelor's Degree in Biological Science
Professional Skills
- Experience leading, managing, motivating and developing technical staff
- Experience leading complex scientific, engineering or technical research projects or programs
- BS/MS in Biochemistry, Chemistry or a Biological Science with at least 10 years of industry experience in pharmaceutical manufacturing and testing
- Experience in raw materials release, sampling, and testing
- Knowledge of regulatory environment (ICH/FDA/EMA regulations) and experience with organizing and writing regulatory submissions
- Experience in working with entrepreneurial stage companies
- Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls
How to write Quality / Control Associate Resume
Quality / Control Associate role is responsible for software, recruiting, database, reporting, manufacturing, design, research, insurance, travel, government.
To write great resume for quality / control associate job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Quality / Control Associate Resume
The section contact information is important in your quality / control associate 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
- Telephone number
Work Experience in Your Quality / Control Associate Resume
The section work experience is an essential part of your quality / control associate 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 / control associate 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 / control associate position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Quality / Control Associate resume experience can include:
- Experience in stability, assay qualification and validation, quality control with respect to antibodies, highly potent cytotoxic active pharmaceutical ingredients and/or antibody drug conjugates
- Previous management experience with demonstrated track record of successful leadership in a biopharmaceutical or equivalent environment
- Hands-on experience with outsourcing of assay development, stability and quality control in support of CMC activities
- Expertise with cGMP (following SOPs, corrective action procedures, audits)
- Recommend the adoption of emerging technologies and the development of new methods and approaches
- Detailed understanding of relevant business and technical knowledge and problem resolution
Education on a Quality / Control Associate Resume
Make sure to make education a priority on your quality / control associate resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality / control associate 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 / Control Associate Resume
When listing skills on your quality / control associate 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 / control associate skills:
- Excellent communication skills for both written and verbal presentations
- Influence and establish effective working relationships in a diverse environment
- Collaborate with others on the direction of activities relevant to long-term objectives. Develop strategies to ensure effective achievement of objectives
- Develop new analytical methods to support manufacturing, process development and process engineering
- Assists in resolving manufacturing technical problems and instrument problems in the lab
- Oversee Quality Control Laboratory including Chemistry, Raw Material, Component Control and Microbiology functions encompassing operations at two plant sites
List of Typical Skills For a Quality / Control Associate Resume
1
Skills For Purchasing / Quality Control Associate Resume
- Develops and execute protocols for inter company analytical method transfers, stability testing of Active Pharmaceutical Components and cleaning validations for plant processes
- Responsible for pharmaceutical product stability program – including accelerated and long-term stability studies
- Responsible for customer interaction regarding quality issues
- Detail oriented knowledge of instrumentation and troubleshooting
- Reviews procedures and processes for compliance with cGMP and FDA regulations
- Travel to other office locations required
2
Skills For Member Services Quality Control Associate Resume
- BS in related science discipline
- Knowledge of Wealth Management Work station, Data Highway Workstation, Collections Notification System, Private Client Order Entry, Advanced Service and Processing System, Siebel Contact Center and Microsoft Outlook and Office Suite
- Self-motivation, enthusiasm and ability to interact within a multi-disciplinary team across multiple locations
- Articulate issues to management in a timely manner
- Demonstrable ability to work proactively and independently, tenacious when necessary
- Review reagent preparation documentation for accuracy, completeness, and compliance with SOPs. Ensure that the documentation is scanned appropriately, and that the reagent log is maintained
- Review KYC for completeness and quality of content. Escalate any issues or hard stops to QC Management to ensure proper protocol is following in a timely manner
3
Skills For Associate, / III, Quality Control Resume
- Assist Senior QC Specialists with the analysis of Special Approval requests for Management approval
- Discuss account issues with BSA/AML team
- Pull and review reports and manage research queries for Managers
- Assist with research on various reports and projects as needed
- Assure operations are conducted in accordance with regulatory requirements and expectations
- Initiate hiring, performance reviews, and staff development activities to improve technical and management capabilities, maintaining career development for QC Analysts and professional development for QC Managers
- Develop, review and approve methods and documentation including product specifications; protocols, SOPs, reporting of testing, analytical method development and validation and stability studies; Design and implement new methodologies to increase efficiencies and productivity
4
Skills For Operations Associate Iv-commercial Lending Quality Control Resume
- Assists QC staff in developing solutions to complex technical and regulatory problems including the investigation and reporting of out of tolerance and/or out of specification reporting
- Participate in interdepartmental meetings and discussions to contribute to and respond do the organizations strategic and operational needs
- Develops and execute protocols for intercompany analytical method transfers, stability testing of Active Pharmaceutical Components and cleaning validations for plant processes
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