Quality / Control Associate Resume Sample

4.7
13 votes

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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
  • Email
  • 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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