MCS Senior Associate Quality Assurance

Job Description

Job Description

Actalent is hiring for a Sr Quality Assurance Associate in the Thousand Oaks area!

Job Description

Sr Associate - Quality Assurance role provides real-time, floor-based QA support for commercial drug substance manufacturing in a GMP environment. You rotate between day and swing shifts approximately every six months, starting on day shift for training, and serve as a key QA liaison for manufacturing and facilities events. The position focuses on cleanroom oversight, electronic batch record review, and quality approvals, while working within a plant QA organization that supports daily operations in drug substance manufacturing areas.

Responsibilities

• Provide real-time, floor-based quality assurance support in drug substance manufacturing areas, maintaining a consistent and purposeful presence on the production floor.
• Oversee cleanroom activities to help ensure compliance with GMP standards and internal procedures.
• Review electronic batch records for accuracy, completeness, and compliance with applicable SOPs and quality requirements.
• Support Manufacturing and Facilities Engineering staff in the execution of their processes and procedures, ensuring appropriate use of quality systems.
• Review, revise, and approve standard operating procedures (SOPs) in alignment with quality and regulatory expectations.
• Review and approve work orders, ensuring they meet quality and documentation standards.
• Provide quality approval for minor deviations, including evaluation of compliance issues and recommending appropriate corrective actions.
• Evaluate documentation and operations against company procedures and quality system requirements, escalating issues as needed.
• Monitor and drive the progress of quality records to completion, ensuring timely closure and proper documentation.
• Act as a QA liaison during manufacturing and facility events, helping to guide quality-based decisions and maintain compliance.
• Represent the Drug Substance Quality Assurance function in cross-functional and matrixed project teams to support departmental operational goals.
• Contribute to and, where appropriate, lead improvement initiatives that enhance quality, compliance, and operational efficiency.
• Communicate effectively with cross-functional partners, providing clear, concise, and timely QA guidance.
• Work both independently and as part of a team to manage multiple tasks, prioritize workload, and meet established timelines.
• Support training and mentoring activities as needed to promote good documentation practices and adherence to GMP requirements.

Essential Skills

• High school diploma or GED with at least 2 years of work experience, or an associate degree with at least 6 months of work experience.
• Hands-on experience in a GMP environment, preferably within biotech or pharmaceutical manufacturing, either in QA or manufacturing roles.
• Demonstrated ability to follow detailed standard operating procedures (SOPs) and maintain required training.
• Strong understanding and practice of good documentation practices (GDP) in a regulated environment.
• Ability to make sound, quality-based decisions to ensure compliance with GMP and internal quality standards.
• Experience working with quality systems to support manufacturing or facilities operations.
• Strong organizational skills with the ability to manage multiple tasks and priorities simultaneously.
• Effective written and verbal communication skills to interact with manufacturing, facilities, and cross-functional teams.
• Ability to work both independently and as a collaborative team member in a matrixed environment.
• Demonstrated critical thinking skills and a practical, hands-on approach to problem solving in a production setting.

Additional Skills & Qualifications

• Bachelor’s degree in Biochemistry, Biology, Chemistry, or a related scientific discipline is preferred but not required.
• Experience in commercial drug substance production or similar biologics manufacturing environments.
• Experience managing projects through to completion while meeting established timelines.
• Experience evaluating documentation and operations according to company procedures and quality requirements.
• Prior involvement in the review and approval of SOPs, work orders, and minor deviations.
• Experience representing QA in cross-functional or matrixed project teams.
• Demonstrated leadership attributes, including the ability to drive improvement initiatives and influence quality culture.
• Comfort working in a cleanroom or controlled environment with adherence to gowning and aseptic practices.
• Openness to training and development, with a focus on practical application of QA principles over purely academic experience.

Work Environment

This role is fully onsite at a manufacturing facility and requires flexibility to work any shift as business needs evolve. You rotate between day shift (approximately 6:00 a.m. to 3:00 p.m.) and swing shift (approximately 3:00 p.m. to 12:00 a.m.) every six months, beginning on day shift for initial training. The position is embedded in a plant quality assurance organization that supports commercial drug substance manufacturing and facilities operations in a GMP-regulated environment. You spend significant time on the production floor and in cleanroom areas, providing real-time QA oversight and interacting closely with manufacturing and facilities engineering teams. The environment is fast-paced, team-oriented, and highly collaborative, with a strong emphasis on compliance, good documentation practices, and continuous improvement. Standard cleanroom and facility safety protocols apply, including appropriate gowning and protective attire where required.

This is a Contract position based out of Thousand Oaks, CA.

The pay range for this position is $30.00 - $30.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Thousand Oaks,CA.

This position is anticipated to close on Sep 7, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email View email address on ziprecruiter.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.