ApTask Global Workforce (AGW) is seeking a Quality Control Senior Associate with a biopharmaceutical company located in Thousand Oaks, CA. This is a 12+ month contract opportunity. This position could be remote or hybrid (3 days onsite/week). Summary: This position will execute deliverables for a project to implement our client's new, fully Electronic Lab Notebook (ELN) system. This is a non-laboratory testing position. This position will be responsible for performing activities towards the design, configuration, and validation of the new ELN system, recreation and/or migration of required master data, and involvement in deployment of production instances at the site(s).
This position will be expected to adhere to established procedures (Standard Operating Procedure, Work Instruction) for safety and cGMP/CFR requirements which includes, but is not limited to, expectations of training and documentation practices. This position will work in a team environment, collaborating with various colleagues in the client network to ensure project commitments are met.
Responsibilities: - Participate in process engineering activities
- Facilitate the development of new business SOPs, Forms, Manuals, etc. using new processes/workflows
- Participate in system requirement, software configuration, and design activities
- Receive and/or verify master data for the site(s)
- Coordinate ELN Template development and review with site SMEs
- Support the development and review of Operational Qualifications
- Execute User Acceptance Testing & Data Migration Verification
- Review and provide input on training materials
- Support training material development by providing inputs and reviews
- Support site Instrument Qualification activities such as planning and execution
Requirements: - Bachelor's degree and 2 years of industry Quality Control or Quality experience OR Associate's degree and 6 years of industry Quality Control or Quality experience OR High school diploma / GED and 8 years of industry Quality Control or Quality experience
- GxP experience, specifically practices and requirements in the testing of biopharmaceuticals
- Experience and knowledge in using electronic lab notebook systems (e.g., Biovia OneLab, ThermoFisher Sample Manager, LabWare, Benchling, etc.)
- Advanced proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint)
- Only candidates available and ready to work directly as ApTask Global Workforce (AGW) employees will be considered for this position.
Pay range: up to $ 45.49 per hour
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 .
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