QA Specialist - Manufacturing

Global Technical Talent, Inc.; Redwood City (CA); On-site; USD 62,000 - 69,000; Part time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

cGMP experience

Batch record review

Manufacturing cleanroom

PAPR PPE familiarity

Data integrity

Effective communication

Education

Bachelor's degree

Tools

Veeva EQV

GQCLIMS

SAP

Job description

QA Specialist - Manufacturing

Location: Redwood City, CA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 12 months
• Pay Rate: $45.00–$50.00 / Hour (USD)
• Shift / Schedule: 5:30 AM – 2:00 PM, Monday – Friday
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

In plain, everyday terms, this person is the quality and safety gatekeeper on the factory floor. When a pharmaceutical plant makes medicine (or ingredients for inhalers, as this client's plant does), every single step must follow strict government health rules. If something isn't done correctly or written down properly, that medicine cannot leave the building. This person's job is to make sure the medicine is made safely, correctly, and with flawless paperwork.

Key Responsibilities

On-the-Floor (OTF) QA Support

• Act as the dedicated QA presence on the manufacturing floor, answering compliance questions and guiding 7–8 manufacturing technicians per shift.

Batch Record Review & Guidance

• Guide technicians on GDP/GMP batch record compliance, assist with appropriate comments/entries, and perform final review and approval of executed batch records.

Material & Product Release

• Review and approve the release of incoming raw materials as well as the finished product (functional excipient powder produced via spray drying for MDI inhalers).

Quality & Compliance Oversight

• Ensure adherence to standard operating procedures (SOPs) and cGMP regulations in real-time production.
• Responsible for QA activities that directly support execution of the process both within the Process Execution Team (PET) and in assigned areas outside of the PET. These activities may include but are not limited to batch release, change control and documentation, equipment and process validation, deviation investigations, SOPs, supplier management, distribution center management, and regulatory interactions.

Major Responsibilities

• Performs the QA review and approval of the following GMP documentation as it relates to the processing equipment and facility to which the position is aligned: Batch Records and associated documentation; Product and Component Release transactions in SAP; Quality Investigations (Deviations, Product Complaints); Standard Operating Procedures.
• Collaborates with other Quality professionals across the organization to ensure consistent application and execution of key quality systems.
• Executes QA processes including batch record review, product and material disposition, and quality issue resolution to maintain the flow of products and documents to meet site objectives.
• Collaborates with other PET/assigned area members and supports process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative, efficient, and effective practices.
• Stays abreast of evolving regulatory compliance practices.

Selected Quality Assurance Activities (Dependent Upon Assigned Area)

• Reads, understands, and follows SOPs and complies with cGMPs.
• Writes new standard operating procedures or revises existing documentation utilizing document management systems.
• Supports the evaluation and disposition of labeling, raw materials, intermediates, and finished products through timely evaluation of batch records, laboratory results, and other cGMP documents.
• Supports the issuance and reconciliation of GMP documentation.
• Electronic system usage with tools such as Veeva EQV, GQCLIMS, and SAP.
• Reviews documented information from their functional area, reports abnormalities.
• Assists supervisor by assembling metrics as requested for their functional area.
• Provides task-oriented training to Specialists.
• Initiates and/or reviews and approves minor deviations; completes tasks related to CAPA and Change Control action items.
• Represents QA on site committees such as SHE, etc.
• Proposes and implements process and other efficiencies as approved by manager.

Required Skills

• Hands-on cGMP experience within pharmaceutical or biotech manufacturing
• Familiarity with executed batch record review and raw material/finished product disposition
• Comfort and ability to work in a manufacturing cleanroom suite wearing a PAPR suit for up to ~80% of the shift
• Attention to Detail: Critical for meticulous batch record auditing, data integrity, and compliance checks
• Effective Communication: Ability to collaborate, guide, and communicate clearly and constructively with manufacturing operators, shift leads, and quality teams
• Adaptability: Comfortable working on the production floor in a dynamic 24/5 manufacturing schedule

Preferred Skills

• Background in Quality Assurance (QA) in a manufacturing plant environment is strongly preferred

Education Requirements

• Bachelor's degree required

Required Experience

• Hands-on cGMP experience within pharmaceutical or biotech manufacturing

Work Environment / Physical Requirements

• Position requires working in a manufacturing cleanroom suite wearing a PAPR (Powered Air Purifying Respirator) suit for up to ~80% of the shift
• Dynamic 24/5 manufacturing schedule — adaptability to production floor environment required

Important Notes

• Interview process: 1st round with manager (virtual/phone); 2nd round onsite
• Candidates should be prepared to confirm comfort with full PPE including a powered air purifying respirator (PAPR) and confirm no medical or physical limitations regarding PPE use or working in confined spaces

About the Client

This client is a biopharmaceutical and life sciences organization engaged in the development and manufacture of specialty pharmaceutical products, including inhaled drug delivery systems, with operations in California. The organization employs quality assurance specialists, R&D scientists, external communications professionals, and clinical operations teams across multiple strategic U.S. locations, and maintains rigorous GMP/cGMP compliance standards across its manufacturing and quality functions.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-18086 Industry: Manufacturing & Operations

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