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Job description
1st Shift: Mon - Fri 8:00 AM to 5:00 PM, OT as needed
What you will do:
The QC Analyst I will perform routine and complex analytical testing to support lot release, stability, and method development, while accurately documenting results and ensuring all work meets cGMP/cGLP standards.
- 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
- Test and record measurements of various product attributes, including pH, concentration, identity, purity, impurities, and bio-potency.
- Perform studies to qualify analytical standards, assay controls, and critical reagents.
- Complete documentation to show that tests have been performed according to approved methods and that all results are recorded accurately.
- Maintain laboratory operations in conformance with cGMP/cGLP standards.
- 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.
- Participate in studies to develop and validate new analytical methods.
What you need:
Required Qualifications
- Bachelor’s degree in biology, biochemistry, microbiology or chemistry
- Experience with various analytical equipment and methods·
- Experience with the application of statistics for data analysis
- Experience with computer software (WORD, Excel, etc.)
Preferred Qualifications
- Master’s degree in biology, biochemistry, microbiology, or chemistry
- 1 - 2 years of recent and applicable industry experience, preferably in a pharmaceutical quality control laboratory
- 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 aseptic technique and mammalian cell cultures
- Experience with inspections, audits, and regulatory agencies/governing bodies.
- Knowledge of GLP/GMP, 21 CFR 211, 21 CFR 820, and ISO13485 standards and regulations
- 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.***
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Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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