Quality Assurance Specialist
90 Digital Drive Novato, CA 94949
Bayside Solutions is seeking a Quality Assurance Specialist to be part of our client’ s team in Novato. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Quality Assurance Specialist
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- This position is responsible for performing Quality Assurance (QA) review of Contract Manufacturing Organization (CMO) manufacturing batch records and associated documentation. This includes receipt, QA review and archival of executed manufacturing batch records and associated documentation such as QC test forms, and updating QA databases. QA review of manufacturing batch records includes verifying conformance to cGMPs, SOPs and batch record process limits
- The ideal candidate will have strong organization and communication skills.
- The individual is expected to communicate well with CMO/Packaging Ops, Quality Assurance, Quality Control, Regulatory Affairs, and Supply Chain both at BioMarin and CMOs.
- Perform client’ s QA review of their Manufacturing executed batch records and associated documentation for compliance with cGMPs, SOPs, and other policies and procedures.
- Ensure adherence to company policies/procedures, regulatory licenses, applicable Quality and Technical agreements, industry standards, and GMP regulations.
- Receive, control, scan and archive CMO executed batch records.
- Prepare lot history folders for Drug Product (DP) lots.
- Update QA CMO datases/Oracle EBS
- Obtain data for complaint investigation, etc.
- Other QA CMO duties as assigned.
- The scope of this position is limited to performing department tasks in accordance with supervisor’ s instructions
Summary of Qualifications:
- BA or BS in a technical discipline (physical or biological sciences preferred).
- 1-5 years of directly related experience in a GMP Quality or Manufacturing environment.
- Strong communication, both written and verbal.
- Working knowledge of process and desktop computers.
- Proven comprehension of technical information and regulatory expectations.