QA Analyst (Stability)
QA Analyst (Stability)
QA Analyst (Stability)
Bayer HealthCare (BHC) makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches. Our Specialty Pharmaceutical business ranks among the top 10 specialty pharmaceutical companies worldwide. Our global research and development is focused in five distinct areas: Diagnostic Imaging, Hematology/Cardiology, Oncology, Specialized Therapeutics, and Women’s Healthcare. As a specialty pharmaceuticals company, we at Bayer HealthCare focus our efforts where we can have the most impact. Our Diabetes Care division is one of the largest self-test diagnostic businesses in the world, supporting customers in 100 countries. Our Consumer Care business is a top competitor in many important product categories including analgesics, cough and cold, and nutritionals. More than 3,000 employees support 14 manufacturing sites in 11 countries dedicated to ensuring the delivery of a secure, high-quality, cost-effective supply of our products around the world. Our Animal Health business in North America is dedicated to making the world a better place for our veterinary customers, their clients, and the animals we all hold dear.
QA Stability We offer a wide variety of competitive compensation and benefit programs. In addition to a competitive base salary, you will be eligible for an array of innovative rewards and recognition programs, variable pay and incentive opportunities as well as benefits coverage beginning on your first day of employment. We are committed to helping our employees maintain a healthy balance between their responsibilities at work and home. You will be eligible for paid time off programs, paid company holidays, flexible work options and numerous site conveniences. We are also committed to supporting your professional development through career ladders, training programs, tuition assistance and professional association events. If you meet the requirements of this unique opportunity, we encourage you to explore how you can make a difference at Bayer by applying now. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.
Responsible for stability program activities including stability data protocol set-up and maintenance, data review and trend evaluation, writing and approving Technical Registration Documents (TRDs) for commercial and clinical drug substances, drug products and diluents, at the Berkeley site and at other Bayer Biotech sites, as assigned. Evaluate and continuously improve QA Stability systems & compliance with requirements, including software & hardware updates, new Quality systems; address compliance challenges.
1. Execute QA Stability program, and maintain compliance with both ongoing & new regulatory requirements.
2. Install and/or maintain stability chambers, including contents.
3. Stability data review and trend analysis, including statistical analysis.
4. Generate stability protocols and reports, typically as Technical Registration Documents (TRD’s) submitted for clinical trials and product licensure.
5. Maintain and improve stability database, and interface with other IT systems (e.g. Quality Control’s Laboratory Information Management System).
6. As required, evaluate statistical software and data reporting tools, institute improvements.
7. Interface with QA, QC, and RA regarding stability indicating methods; assure qualification and validation are compliant with regulatory expectations.
8. Provide cGMP compliance support for QC stability programs and related activities.
Bachelor’s degree in a scientific/ technical field. Advanced degree is preferred.
Minimum Experience 6+ years of experience in pharmaceutical or related industry or an equivalent combination of education and experience. 3+ years of experience in Quality Assurance/Quality Control/Manufacturing environment in the biopharmaceutical or biotechnology industry supporting late stage clinical or licensed product.
A well-rounded technical background encompassing analytical methods, instrumentation, computerized systems, biology, chemistry, microbiology, statistics and/or thermodynamics is desirable.
Familiarity with biopharmaceutical production and testing is required.
Ability to solve complex technical problems.
Familiarity with statistical analyses related to pharmaceutical / biotech drug product stability, including statistical software programs and stability software modules such as SAS JMP. Familiarity with cGMP and worldwide regulatory regulations and harmonization requirements related to stability of pharmaceutical and biotech products.
Previous experience is preferred in QC lab or QC stability program in a pharmaceutical or biotech environment.
Bayer is an Equal Opportunity Employer Minorities/Females/Protected Veterans/Disabled
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Desired Skills and Expertise
2 - 5 years
Salary / package