Aptask Global Workforce (AGW) is seeking a MCS Manufacturing Sr. Associate - Drug Substance Operations for an Onsite position with a Global Biotechnology Company located in Thousand Oaks, CA. This is a 12+ month contract opportunity. This role will provide support and subject-matter expertise as a Process Owner for the downstream drug substance operations. The ideal candidate will support quality oversight of analytical testing in manufacturing, utilize project management skills to lead complex projects, and apply technical knowledge in a GMP environment to improve process performance and support the implementation of new technologies.
Responsibilities: - Provide support and subject-matter expertise in a process owner (PO) role for the downstream drug substance operations
- Support Quality Oversight of analytical testing in manufacturing through comprehensive data capture and analyses using Spotfire
- Utilize project management skills to lead complex projects or components of projects with successful results
- Troubleshoot quick issues in a timely manner and run function testing to resolve and improve process performance
- Write protocols and reports in support of validation, function testing, equipment commissioning and qualification, and change management
- Own Quality Records, such as CCMS, CAPA, and CAPA-EV
- Support operational readiness of new technologies, equipment, or processes
- Develop and own drug substance manufacturing processes and procedures
- Draft, revise and ensure GMP manufacturing documents (SOPs, FORMS) align with user requirements for new technologies
- Work various shifts (day, swing, graves, weekends, holidays) as instructed by the production schedule
Requirements: - High school/GED + 2 years of work experience OR Associate's degree and 6 months of work experience OR Bachelor's degree
- Technical knowledge of downstream operations
- Project management skills
- GMP knowledge and experience in a GMP environment
- Experience running functional tests and writing protocols
- Must be able to work in a clean room environment wearing steel toe shoes, full clean room gowning, hairnet and gloves
Desired skills: - High school/GED + 4 years' work experience
- Associate degree + 2 years' work experience
- Bachelor's Degree + 6 months' work experience
- Master's Degree
Pay range: up to $33.28 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. 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
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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