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At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Spec QA Release

This position plays a critical role in evaluating and QA approving documents (e.g., batch records and manufacturing process records) and ensuring products are safe, free of defects and meet manufacturer guidelines before they’re shipped to retailers, suppliers and consumers. This position is responsible for using scientific principles, thorough analysis and a compliance minded thought processes to ensure cGMP requirements and product quality attributes are met.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Spec QA Release, are to:

+ Review and approve API/finished product batch and manufacturing records using scientific principles.

+ Perform final inspection of product vials and packaged material to ensure products are free of defects and meets specifications. Determine acceptability or rejection of vial/packaged product and take necessary steps to remediate potential issues (e.g., halting the production process)

+ Represent QA in interactions with Manufacturing, QA, QC, Supply Chain and Regulatory inspections • Enters, reviews and queries data in electronic systems (e.g., BASICS, Dev@COM, LIMS) to support lot release activities

+ Writes and revises SOPs. Review and approval of specific area documentation (e.g., change control, deviation) using scientific principles as needed.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

+ Bachelor's Degree.

+ Experience in the biopharmaceutical, biologics, medical device or related industry along with knowledge, understanding and ability to consistently implement cGMP concepts or a combination of equivalent experience and education. Must be able to understand, review and approve pharmaceutical manufacturing records.

+ Must be able to understand the concepts and interconnectivity of how individual tasks affect patients, departmental and site goals

+ Must be able to exercise independent thought and judgement

+ Must be able to work independently with limited oversight from senior management

+ Has general knowledge of the techniques used in other disciplines in the QC department and has a general understanding of how results from each discipline impact the quality of the drug substances manufactured.

+ Operates effectively in a fast-paced work environment.

+ Translates ambiguous goals into actionable plans.

+ Maintains flexibility in a dynamic work environment

+ Understands GMP documentation with a high level of proficiency.

+ Advises junior peers on GMP documentation practices

+ Ability to interpret and evaluate data and summarize results

+ Ability to pass annual vision testing and annual inspection qualification

+ Must be able to work without wearing makeup, hand lotion or jewelry

+ Must be able to read, write, speak and comprehend English in order to understand instructions contained in SOPs, BPRs, etc.

+ Detail orientation, good communication and interpersonal skills

+ Ability to work off shift hours and weekends when necessary

Preferred Experience:

+ Bachelor's Degree in a science or technical field.

+ 6 years of experience in the biopharmaceutical, biologics, medical device or related industry along with knowledge, understanding and ability to consistently implement cGMP concepts or a combination of equivalent experience and education. Must be able to understand, review and approve pharmaceutical manufacturing records.

Employees can expect to be paid a salary of between $93,840 – $120,760. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc. This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors. This posting will be available for application until at least: 12/20/2025

YOUR APPLICATION

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.

To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Bayer is an E-Verify Employer.

**Location:** United States : California : Berkeley

**Division:** Pharmaceuticals

**Reference Code:** 859375

Contact Us

**Email:** [email protected]