Senior Specialist, Field Quality QA Operations
About The Position
This floor-based role maintains quality oversight and GMP compliance in day-to-day manufacturing operations. The Senior Field QA Specialist reviews Manufacturing Batch Records, performs real-time on-floor exception and logbook reviews, conducts GMP area walkthroughs, and supports return-to-service walkthroughs to confirm manufacturing areas and equipment are cleaned, calibrated, and ready for production. The specialist works closely with Manufacturing Operations to investigate and resolve manufacturing issues, contributes to authoring and revising quality SOPs, supports review and closure of no-impact manufacturing deviations, and conducts proactive area inspections and readiness reviews. The role supports real-time quality assurance, batch release readiness, and audit preparedness. The schedule is Monday through Friday, 7:00 a.m. to 3:30 p.m. Work is primarily in a modern manufacturing facility, where awareness of pressurized liquids and gases, steam, and hazardous chemicals is required. PPE may be required in some facility areas, including appropriate gowning for clean-room work.
Requirements
- Four years of Quality Assurance experience in the pharmaceutical or medical device industry.
- Experience reviewing batch records.
- A bachelor's degree in science, engineering, biochemistry, or a related discipline, or equivalent, is preferred.
- Knowledge of US and EU cGMP regulations and guidance.
- Ability to exercise judgment within defined practices and policies, select methods and techniques to obtain solutions, coordinate decisions with leads or a supervisor, and notify management as appropriate.
- Ability to apply defined processes to assigned work, with assignments and supervisory attention based on demonstrated capabilities.
Nice To Haves
- Knowledge of biotech bulk and finished-product manufacturing and analytical testing.
- Knowledge of electronic or paper batch-record systems, DeltaV, and other electronic systems used for laboratory test results, inventory management, investigations, and equipment tracking and maintenance.
Responsibilities
- Provide quality floor support for complex manufacturing activities.
- Review manufacturing batch production records in support of product release, in accordance with specifications and SOPs.
- Conduct walkthroughs of GMP areas and document observations and areas of concern.
- Train new team members on routine facility Quality tasks.
- Support return-to-service and Manufacturing inspection-readiness walkthroughs as needed and in accordance with procedures.
- Ensure electronic and paper documentation requiring QA review complies with corporate and site procedures, cGMP regulations, and other industry guidelines.
- Work with Manufacturing Operations to investigate and resolve manufacturing issues.
- Contribute to authoring and revising quality SOPs.
- Support review and closure of no-impact manufacturing deviations.
- Conduct proactive area inspections and readiness reviews.
Benefits
- Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings.
- Eligible U.S.-based exempt employees receive Flexible Time Off without a set accrual limit, subject to manager approval, and 11 paid company holidays annually.
- Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires, subject to manager approval, 11 paid company holidays, and 3 optional holidays.
- Depending on eligibility, additional time off may include paid sick leave, up to two paid volunteer days per year, summer-hours flexibility, and leaves for medical, personal, parental, caregiver, bereavement, or military needs.
- Eligible employees receive an annual Global Shutdown between Christmas Day and New Year's Day.
- May be eligible for discretionary cash incentives and stock opportunities.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
