GMP Quality Specialist; ONSITE

GMP Quality Specialist (ONSITE)

Contract opportunity with Yoh Staffing's client working in Hercules, CA. Pay Rate: $40-45/hr onsite.

• A typical day for the candidate involves actively supporting Quality Operations through a mix of hands‑on floor engagement and strategic oversight. They begin the day by attending Tier 2 Gemba meetings and providing real‑time support to manufacturing teams, ensuring compliance with quality standards.
• Responsibilities include performing batch record reviews and product releases, reviewing and approving stability studies and labeling (such as FAI and field bulletins), and offering guidance on regulatory standards.
• Ensures training compliance, chairs Material Review Board (MRB) meetings, participates in Environmental Control Meetings, coordinates Quality Notifications (QNs), supports internal and external audits, and updates quarterly quality metrics. This role requires strong collaboration, attention to detail, and the ability to lead and influence cross‑functional teams to uphold product and process integrity.
• Driving Compliance and Risk Mitigation: QA Specialists III are instrumental in ensuring that products and processes meet regulatory and internal quality standards.
• Enhancing Product and Process Quality:
  By reviewing batch records, managing quality documentation, and participating in root‑cause analysis, QA Specialists III help identify and correct systemic issues.
• Acting as Subject Matter Experts: QA Specialists III are designated as the primary experts for specific product regulatory compliance, in accordance with ISO
  13485 standards.
• Supporting Internal /External Audits – They play a key role in audit readiness, in the Bio‑Rad requalification process, QA specialists coordinated responses to audit requests and ensured timely delivery of quality documentation.

• Associate degree or equivalent in Biology, Chemistry, or a related field
• 2+ years of experience in a regulated manufacturing industry, or an equivalent combination of education and experience
• Familiarity with GMP and quality system standards (e.g., ISO 13485, FDA 21 CFR 820/210/211)
• Working knowledge of device/drug/biotech manufacturing processes
• Experience with nonconformance investigations, deviation management, batch record review, and product release
• Proficiency in QMS databases, SAP, and Microsoft Office
• Strong attention to detail, multitasking, time management, and communication skills

• This is a unique opportunity to support our client; one of the world’s largest biotechnology companies. Medical benefits and 401K are available.
• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• Met Life Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly ePayroll
• Referral Bonus Programs
• Certification and training opportunities

Recruiter:
Lisa Hughes

Estimated Min Rate: $40.00

Estimated Max Rate: $45.00

All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

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