QA Specialist - Manufacturing

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.

At the QA Specialist level, the incumbent is not necessarily performing all the major responsibilities of the role immediately. The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs. Over time, the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role.

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 QA 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.

Work Environment / Physical Requirements

• Position requires working in a manufacturing cleanroom suite wearing a powered air purifying respirator (PAPR) suit for up to approximately 80% of the shift.
• PPE required, including a powered air purifying respirator (PAPR); candidates must be able to wear full PPE and must have no medical or physical limitations regarding the use of PPE or working in confined spaces.
• Dynamic 24/5 manufacturing environment.

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

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 spanning key strategic locations across the United States. The organization employs quality assurance specialists, R&D professionals, external communications directors, and clinical and regulatory experts who collaborate across science-led, compliance-driven manufacturing and research teams to advance patient-centered therapies.

About GTT

GTT is an NMSDC-certified Minority Business Enterprise (MBE) headquartered in Portsmouth, New Hampshire. GTT is a subsidiary of Chenega Corporation, an Alaska-based company and one of the largest Alaska Native-owned corporations. An Inc. 5000 honoree and one of SIA's Best Staffing Firms to Work For, GTT connects professionals with Fortune 500 organizations across IT, engineering, construction, utilities, life sciences, financial services, and healthcare throughout the U.S. and Canada. We're committed to diverse, inclusive workplaces and to placing people in roles where they can do their best work.

Job Number: 26-18086 Industry: Manufacturing & Operations

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