Quality Control Analyst I - 1St Shift - Starting At $34.54/Hr

Why RA/QA 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 RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World’s Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

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

Our benefits include bonuses; healthcare; insurance benefits; retirement programs; stock based 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.

Who we want:

• Collaborative partners. People who function well in a team to complete projects on schedule with high quality and who adapt quickly to changes in priorities.
• Curious learners. People who quickly assimilate new processes and procedures and contribute to the success of the GQO team and Stryker.
• Detail-oriented critical thinkers. People who can perform consistent, high-quality work and can contribute effectively as a team member when obstacles arise.

What you will do:

• Monitor and record equipment parameters (temperature charts, gas levels, and liquid nitrogen levels).
• Monitor and maintain adequate quantities of laboratory supplies.
• Assist the Quality Control team with technical evaluations of non-conforming test results and events to determine root cause; recommend corrective actions.
• Perform routine procedures and complex analytical methods for lot release and stability testing of raw materials, reagents, and products, and prepare technical reports and documentation
• Complete documentation to show that tests have been performed according to approved methods and that all results are recorded accurately.
• Test and record measurements of various product attributes, including pH, concentration, identity, purity, impurities, and bio-potency.
• Participate in studies to develop and validate new analytical methods.
• Perform studies to qualify analytical standards, assay controls, and critical reagents.
• Maintain laboratory operations in conformance with cGMP/cGLP standards.

What you need:

Required Qualifications

• Experience with various analytical equipment and methods·
• 1 - 2 years of recent and applicable industry experience, preferably in a pharmaceutical quality control laboratory
• Experience with computer software (WORD, Excel, etc.)
• Bachelor’s degree in biology, biochemistry, microbiology or chemistry
• Experience with the application of statistics for data analysis

Preferred Qualifications

• Master’s degree in biology, biochemistry, microbiology, or chemistry
• Advanced technical knowledge of analytical methods and function and maintenance of related instruments (including, but not limited to HPLC, UHPLC, UV/Vis spectrophotometers, SDS-PAGE, capillary electrophoresis, brightfield and fluorescence microscopy, cell counters, protein analysis)
• Experience with inspections, audits, and regulatory agencies/governing bodies.
• Experience maintaining qualified laboratory equipment and creating/reviewing technical documents for an FDA-regulated laboratory ***Highly qualified candidates with alternate, but applicable experience will be considered, including related academic and commercial laboratory research.***
• Knowledge of GLP/GMP, 21 CFR 211, 21 CFR 820, and ISO13485 standards and regulations
• Experience with aseptic technique and mammalian cell cultures

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com