Quality Control Associate
- Thousand Oaks, CA
- Permanent
- Full-time
The ideal candidate will have a bachelor’s degree in a scientific discipline and prior academic or industry laboratory experience. They should be familiar with basic lab techniques including pipetting, weighing, titration, and pH measurement, and be comfortable working in a GMP-regulated environment. Experience with chromatography or protein handling is a plus, but not required, as full training will be provided. Strong attention to detail, good documentation practices (GDocP), and comfort with lab notebooks and SI pages are essential.Responsibilities:
- Report, evaluate, trend and approve analytical data.
- Troubleshoot, solve problems and communicate with stakeholders.
- Generate complete, accurate, and concise documentation using electronic systems and laboratory notebook.
- Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
- Execute protocols and perform assay transfer/validation and equipment qualification/verification.
- Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
- Responsible for CEMS on call pager.
- May participate in lab investigations.
- May provide technical guidance.
- May train others.
- May represent the department/organization on various teams
- May interact with outside resources
- cGMP Experience
- Experience in Capillary electrophoresis
- Experience using Empower CDS, LIMS and/or SmartLab
- Experience using Waters H-Class UHPLC and Agilent HPLC instrumentation
- Experience and knowledge of Data Integrity Requirements of QC Systems
- Proficient in Microsoft Office (e.g. Outlook, Word, Excel, PowerPoint)
- Excellent problem-solving capabilities and attention to detail
- Experience of collaboration within and across functional areas and outstanding customer service focus
- Excellent written and verbal communication skills
- Ability to adhere to regulatory requirements, written procedures and safety guidelines
- Ability to evaluate documentation/data according to company and regulatory guidelines
- Ability to organize work, handle multiple priorities and meet deadlines
- Strong written and oral communication skills
- Must learn and comply with safety guideline and cGMPs.
- Laboratory Techniques & Analytical Skills
- Critical Thinking & Problem Solving
- Attention to Detail & Documentation
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