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 hourIf 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.
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