Quality Assurance Specialist, Site Compliance
BAYER - Berkeley, CA

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Bayer HealthCare (BHC) makes an important contribution to human and animal health with its innovative products and by researching new therapeutic approaches promoting science for a better life throughout everything that we do. 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 focus our efforts in areas of high unmet medical need and where we can have the most impact. Our Medical Care division consists of Diabetes Care and Radiology and Interventional. The Diabetes Care division is one of the largest blood glucose monitoring businesses in the world, supporting customers in 100 countries. Radiology and Interventional is the world's leading supplier of contrast agents and injection systems for diagnostic and therapeutic medical procedures. The business also supplies mechanical systems for removing thrombi from blood vessels. 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. Discrepancy Management 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. Position: Major Tasks

  • Review and approval of incident reports (IRs) and CAPAs using
scientific principles as needed. Ability to trend and monitor IRs and
CAPAs.
  • Ensures required inputs from critical business partners (e.g.
Quality Assurance, Quality Control, Technical Operations, Supply Chain)
meet cGMP requirements within established timelines.
  • Writes and revises SOPs. Provides technical guidance to
Technical Reviewers. Supervise document review by Technical Reviewers
as required.
  • Provides effective leadership in training and developing internal
customers/stakeholders. Supports workforce diversity, quality and
safety.
  • Represents QA in interactions with Manufacturing, QA, QC,
Production Planning & Logistics, Bayer partners, Supplier
Auditors/Inspectors, and regulatory agency inspections.
  • Assists and may lead on special projects with moderate
complexity.
Position: Skills
Minimum Education: Bachelor†s degree in a scientific discipline
Minimum Experience: 5-6 years of related experience in the
biopharmaceutical industry with an emphasis in Quality Assurance,
Quality Control, Engineering, or Manufacturing in a GMP regulated
industry or equivalent combination of education and experience. Must be
able to understand and review manufacturing process discrepancies and
corrective and preventive actions.
Special Skill/Knowledge: Proven ability as a team player and
leader.
  • Excellent analytical and problems solving skills.
  • Proven ability to express views and opinions.
  • Listens well and accepts conflicting point of views.
  • Detail oriented, good communication and interpersonal skills.
  • Knowledge of GMP regulations and understanding of FDA and other
regulatory guidelines.

Bayerjobs.com - 20 months ago - save job
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For when you can't "bayer" the pain, Bayer Corporation makes your medicine. The US headquarters of pharmaceuticals and...