Senior Quality Control Analyst III

  • Job Reference: 425084793-2
  • Date Posted: 17 November 2021
  • Recruiter: Stryker Corporation
  • Location: Franklin, Tennessee
  • Salary: On Application
  • Sector: Science & Technology
  • Job Type: Permanent

Job Description

COVID-19 vaccination requirements

Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, COVID-19 vaccines will be required for all Stryker US employees effective January 4, 2022, as well as all new US employees joining our company. Fully vaccinated persons are those who are >=14 days post-completion of the primary series of an FDA-authorized COVID-19 vaccine. If you are applying to a sales and field role which requires access to customer accounts as a function of your job, you may be required, depending on customer requirements, to obtain the COVID-19 vaccination before the January 4 effective date of Stryker's vaccine policy. For more information, please visit our COVID-19 Vaccination Requirements FAQs page.

Why join Stryker?

We are proud to be named one the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com

Our benefits include bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards - not to mention various social and recreational activities.

Why regulatory affairs/quality assurance at Stryker?

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities.

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team:

Who we want-

* Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
* Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
* Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.

What you will do-

* The Quality Control Analyst III is responsible for the execution of QC analytical methods to complete Augment product and drug substance lot release and stability programs.
* Performs stability programs and maintains project plans to track progress to support Manufacturing and Supply Chain.
* Supports method development, validation and transfer of assays to contract laboratories and manufacturers. Manages QC laboratory supply purchasing, including capital expenses, and professional services to meet AOP.
* Responsible for procuring, managing and maintaining validated laboratory equipment. Writes scientific documentation in support of company's AUGMMENT® product lines and regulatory filings. Supervises QC technicians and temporary staff to complete assigned work tasks, training, and development. This position will also serve to support QS/QOps in auditing qualified suppliers for the laboratories and SMEs for external and internal audits
* Perform rhPDGF-BB AUGMMENT® product and drug substance release and stability programs and plan QC personnel work schedules to ensure adequate AUGMMENT® supply.
* Support method development, validation and transfer of assays to/from contract laboratories and manufacturers.
* Create and revise documentation including test methods, SOPs, reports, and regulatory documents supporting the company's products.
* Manage QC supply purchasing, capital expenses and professional services to meet AOP budget
* Extend the analytical capabilities of the lab by transferring/creating and validating new analytical methods
* Design and execute scientific studies in a laboratory setting, including analytical method development, method transfer/validation.
* Perform laboratory wet-bench assays such as protein chemistry and protein analytical methods, ELISA, gel electrophoresis
* Generate and execute project plans

What you need-

Required

* Bachelor's degree in biology, biochemistry or chemistry required
* Minimum of 4+ years of recent and applicable industry experience, preferably in a pharmaceutical quality control lab.
* Demonstrate aseptic technique and recent experience with mammalian cell culture and cell based assay required
* Experience with inspections, audits and regulatory agencies/governing bodies
* Experience with computer software (WORD, Excel, etc.)
* Experience with the application of statistics for data analysis
* Highly qualified candidates with alternate, but applicable experience will be considered, including related academic and commercial laboratory research.

Preferred

* Master's degree in biology, biochemistry or chemistry preferred
* Extensive knowledge of GLP/GMP, 21 CFR 211, 21 CFR 820, and ISO13485 standards and regulations required
* Knowledge of OSHA/EPA/DOT regulations for biohazard/hazardous waste.
* DOT certification a plus
* OSHA certification a plus

* Experience maintaining qualified laboratory equipment and creating/reviewing technical documents for an FDA-regulated laboratory

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at

About Stryker

Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com