MCS Manufacturing Sr. Associate

Aptask Global Workforce (AGW) is seeking a MCS Manufacturing Sr. Associate for a contract position with a Global Biotechnology Company located in Thousand Oaks, CA. This is a 12+ month contract opportunity.

This role is focused on owning Corrective Actions (CAPAs) and Effectiveness Verification (EV) records within a regulated manufacturing environment. The ideal candidate will have strong project management skills to coordinate corrective actions, partner with cross-functional teams including manufacturing, engineering, and quality, and drive projects to completion. Experience in biotechnology, pharmaceutical, or other highly regulated industries is essential.

Responsibilities:

• Own Corrective Actions (CAPAs) and Effectiveness Verification (EV) records in support of major and trend deviations
• Maintain close interaction with Manufacturing leads, engineering, Process Development, Quality Controls, Supply Chain, and quality functions to mitigate root causes
• Lead discussions to reduce, correct, mitigate, and prevent the reoccurrence of events
• Advise management on CAPA/EV progress, product/process risk, and potential delays
• Manage deviation investigation CAPAs and EVs, including assembling teams and ensuring compliant documentation
• Drive improvements to the investigation process
• Defend investigation CAPAs/EVs to regulatory inspectors and internal auditors
• Collaborate cross-functionally to ensure the Quality Management System processes are completed in accordance with established procedures
• Alert senior management of quality, compliance, supply, and safety risks

Requirements:

• High school/GED with 2+ years of work experience, or an Associate's degree with 6+ months of work experience, or a Bachelor's degree
• Direct experience with deviation investigations, CAPA processes, and regulated quality systems
• Demonstrated project management ability and experience leading teams
• Experience owning CAPA records, coordinating corrective actions, and driving projects to completion
• Ability to work in a team matrix environment and build relationships with partners
• Excellent written and verbal communication skills
• Experience managing multiple concurrent workstreams
• Must be comfortable working in a hybrid environment (typically 2-3 days onsite per week)
• Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position.

Desired skills:

• 5+ years of related work experience in the biotech or pharmaceutical industry
• Degree in Science or Engineering

Pay range: Up to $33.28 per hour

If you have the described qualifications and are interested in this exciting opportunity, apply today!

Aptask Global Workforce (AGW)

ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.

Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website ;br>
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.