Senior Quality Assurance Specialist

Senior Quality Assurance Specialist – Batch Record Reviewer

Kelly® Science & Clinical is seeking a Senior Quality Assurance Specialist for a contract position in Irvine, CA. If you’re passionate about quality, compliance, and manufacturing in a cGMP environment, trust the experts at Kelly® Science & Clinical to help advance your career.

Pay: $34-38/hour depending on experience

Schedule:
Mon-Fri 8am-5pm

Our Client is a regulated manufacturing organization operating in a cGMP environment. This role is responsible for the review, issuance, and maintenance of batch records and quality documentation to ensure compliance with internal procedures, regulatory requirements, and applicable quality standards.

• Review Batch Records (In-Process, Raw Materials, and Final Release) for the release of raw materials and components.
• Review all attachments corresponding to Batch Records, including tickets, charts, spreadsheets, stickers, product-colored sheets, checklists, MBRs, Packaging Reports, and Lab Reports.
• Generate and disposition product certificates and release documentation (Certificates of Compliance and Certificates of Analysis) for COS, TX, and CA.
• Ensure Batch Records are complete, accurate, and contain all required attachments in a timely manner.
• Facilitate product release by ensuring proper documentation compliance within a cGMP environment.
• Support Right First Time initiatives.
• Ensure accuracy, integrity, and completion of quality documentation and quality memos.
• Issue Batch Records and controlled copies as required.
• Issue copies of Batch Records, OOS documentation, Quality Reports, Lab Reports, Protocols, and Validation Reports to customers or the Sales department as necessary.
• Maintain executed Batch Records and all related documentation.
• Initiate updates to Batch Records, product specifications, and quality procedures through change control when required.
• Support regulatory inspections, compliance audits, and other quality-related activities.
• Assist with new product introduction and development projects.
• Supply documentation in a timely manner upon request.
• Create quality documentation, including training materials and SOPs.
• Maintain compliant Batch Records in accordance with established specifications and cGMP standards.
• Generate Certificates of Analysis (CoA) and Certificates of Compliance (CoC) for finished products as applicable.
• Collaborate with supervisors and technicians to ensure cGMP procedures remain current.
• Assist the QA Manager with internal Quality Assurance audits.
• Perform other related duties as required.

• Bachelor’s degree in a scientific discipline.
• Minimum of 3 years of experience in Quality Control or Quality Assurance within a manufacturing environment; pharmaceutical experience preferred; or an equivalent combination of education and experience.
• Experience with HPLC, NMR, UV Vis required.
• 2-3 years of laboratory experience preferred.
• Strong organizational skills with exceptional attention to detail.
• Strong written, verbal, and interpersonal communication skills with the ability to work cross-functionally.
• Ability to manage multiple assignments and shifting priorities effectively.
• Ability to learn and utilize computerized systems for daily task execution.
• Proven ability to prioritize work, meet deadlines, and manage workload independently.
• Ability to read, write, and comprehend English, including instructions, correspondence, policies, and procedures.
• Ability to present information clearly, respond to questions professionally, and address concerns in one-on-one and small group settings.
• Ability to interpret and analyze abstract or incomplete verbal and written instructions.
• Proficiency in Microsoft Word, Excel, Access, and other relevant software applications.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce.

Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.