Onsite Pharma QA Specialist — cGMP & Batch Records

Global Technical Talent, Inc.; Redwood City (CA); Vor Ort; USD 62.000 - 69.000; Teilzeit

Zusammenfassung

Global Technical Talent, Inc. is seeking a QA Specialist for a 12-month contract in Redwood City, CA.

The role focuses on ensuring product quality and regulatory compliance on the manufacturing floor, with emphasis on cGMP, batch records, and release of materials and finished products. The ideal candidate will operate in a cleanroom environment wearing a PAPR, guide technicians, review documentation, and support CAPA and change control activities to keep production compliant and moving

Qualifikationen

• Hands-on cGMP experience in pharmaceutical or biotech manufacturing.
• Experience reviewing batch records and material disposition.
• Ability to operate in a cleanroom and wear PAPR PPE for extended shifts.

Aufgaben

• QA on-floor support guiding 7–8 technicians per shift.
• Review GDP/GMP batch records and approve entries.
• Review and release incoming materials and finished product.
• Ensure SOPs and cGMP compliance in real-time production.
• Participate in CAPA, change control, and regulatory interactions.
• Collaborate across PET and QA teams to improve processes.
• Stay updated on evolving regulatory practices.

Kenntnisse

cGMP experience

Batch record review

Manufacturing cleanroom

PAPR PPE familiarity

Data integrity

Effective communication

Ausbildung

Bachelor's degree

Tools

Veeva EQV

GQCLIMS

SAP

Jobbeschreibung

Global Technical Talent, Inc. is seeking a QA Specialist for a 12-month contract in Redwood City, CA.

The role focuses on ensuring product quality and regulatory compliance on the manufacturing floor, with emphasis on cGMP, batch records, and release of materials and finished products. The ideal candidate will operate in a cleanroom environment wearing a PAPR, guide technicians, review documentation, and support CAPA and change control activities to keep production compliant and moving