Senior Associate QA - GMP

Senior Associate QA - GMP

Location: Thousand Oaks, CA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 6 months
• Pay Rate: $30.00 $33.00 / Hour (USD)
• Shift / Schedule: Rotating shifts Day Shift: 6:00 AM 3:00 PM; Swing Shift: 3:00 PM 12:00 AM. Rotation occurs every 6 months. Must be flexible worker may start on any shift. Shift will change based on the business being supported.
• 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

The manager is seeking a Senior Associate, Quality Assurance (MCS) to provide real-time, floor-based QA support at the client's USTO site. This fully onsite role involves rotating between day and swing shifts every six months, beginning on day shift for training. The position supports commercial drug substance production and requires cleanroom oversight, batch record review, and acting as a QA liaison during manufacturing and facility events. Ideal candidates will have hands-on QA or manufacturing experience in a GMP environment (preferably within biotech or pharmaceutical manufacturing) with strong critical thinking skills prioritized over academic credentials. A bachelor's degree in Biochemistry, Biology, Chemistry, or related scientific disciplines is preferred but not required. The manager is open to training strong candidates but will not consider those who are purely academic or significantly overqualified without clear justification.

This position supports the client's Quality Assurance program under the Plant QA organization, providing daily oversight of the Drug Substance manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent the functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.

Key Responsibilities

• Provide real-time, floor-based QA support including purposeful presence on the manufacturing floor
• Perform electronic batch record review
• Conduct SOP revision and approval
• Perform work order approval
• Perform quality approval of minor deviations
• Provide compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their daily processes, procedures, and use of quality systems
• Evaluate compliance issues, provide recommendations, and assure progress of quality records to completion
• Represent the functional area for the Drug Substance Quality Assurance department in the execution of projects necessary to achieve departmental operational goals
• Work in a team matrix environment

Required Skills

• Self-driven / self-starter
• Strong communication skills
• Strong teamwork ethic

Preferred Skills

• Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices
• Ability to make quality-based decisions in order to ensure compliance
• Experience managing projects through to completion and meeting timelines
• Experience evaluating documentation and operations according to company procedures
• Experience working with Quality Systems
• Strong organizational skills and ability to manage multiple tasks at one time
• Effective communication skills (both written and verbal)
• Demonstrated ability to work as both a team player and independently
• Display leadership attributes and drive improvement initiatives

Education Requirements

• High school diploma / GED with 2 years of work experience OR Associate's degree with 6 months of work experience OR Bachelor's degree
• Bachelor's degree in Biochemistry, Biology, Chemistry, or related science field (preferred)

Required Experience

• Minimum 2 years of work experience (if highest education is high school/GED); minimum 6 months of work experience (if Associate's degree)

Nice-to-Have Experience

• Hands-on QA or manufacturing experience in a GMP environment, preferably within biotech or pharmaceutical manufacturing

Work Environment / Physical Requirements

• Fully onsite at USTO site
• Cleanroom environment GMP manufacturing setting
• Rotating shift schedule (day and swing), rotating every 6 months
• Must be flexible to start on any shift

Important Notes

• Interview Process: Phone/video call interview with manager, followed by a video call with team members.
• Red Flags: No GMP experience and job switching in short periods of time will be considered disqualifying.

Benefits

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

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: 26-10214 Industry: Manufacturing & Operations

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