Website Genesis10
Genesis10
Company : Genesis10
ApTask Global Workforce (AGW) is seeking an MCS Quality Assurance Specialist with a biotechnology company. This is a 12 month contract opportunity located in Thousand Oaks, CA.
Summary
This position supports ***'s Quality Assurance program under the ATO Plant Quality Assurance organization providing oversight of Commissioning, Qualification, and Validation (CQV) processes in Cell Banking, Drug Substance, Drug Product Filling, Drug Product Packaging/Labeling, General Utility, and Quality Control GMP areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of CQV related processes, procedures, and use of quality systems.
Ideal Candidate: 1 YOE in Commissioning, Qualification, and Validation experience.
Responsibilities:
- Providing oversight of Commissioning, Qualification, and Validation (CQV) processes in Cell Banking, Drug Substance, Drug Product Filling, Drug Product Packaging/Labeling, General Utility, and Quality Control GMP areas.
- Providing support and compliance oversight to Manufacturing and Facilities & Engineering staff in the execution of CQV related processes, procedures, and use of quality systems.
- Ensuring adherence to equipment and computer validation standards and procedures.
- Participation in CQV design, review of test protocols, analysis of CQV results, and oversight of summary reports.
- Providing guidance and setting standards in producing quality documentation.
- Serving as an advisor to Engineering, IS and Manufacturing functions.
- Providing testing and IT compliance guidance.
- Providing timely and effective response and follow-through in the resolution of IT compliance issues.
- Executing quality oversight directly in *** Quality systems.
Requirements/Qualifications:
- Bachelor’s degree in engineering, Biochemistry, Biology, Chemistry, or related science field.
- Demonstrated ability to perform or provide oversight of GMP operations including following detailed SOPS, maintaining training, maintaining data integrity principles, and good documentation practices.
- Experience managing projects through completion while meeting timelines.
- Evaluating documentation and operations according to company procedures and related regulations.
- 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.
- Solid understanding and application of aseptic behaviors and principles.
Pay range: up to $48.57 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, please apply!
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 (url removed)
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.