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QC Analyst II (Reviewer)

Newark, CA 94560

Posted: 09/11/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 614144 Is job remote?: No Country: United States

Job Description


JOB SUMMARY:

The QC Analyst II of analytical team will be responsible for testing of in-process, lot release and stability samples for various commercial and clinical drug products. Author and revise SOPs, deviations, CRs and LIRs. Areas of responsibility include but are not limited to testing samples for Appearance, pH, UV and water content, HPLC, ELISA, western blot and SDS-PAGE as needed. Participate or lead investigations, reports and process optimization activities as needed. Actively participate in group and project teamwork.

ESSENTIAL DUTIES and RESPONSIBILITES:
  • Perform routine and non-routine release, in-process and stability testing for drug substance, drug product, and other critical reagents and documentation under cGMP.
  • Perform Analytical assays such as HPLC (SEC, IEX, HIC, RP, affinity), ELISA, SDS-PAGE, Western Blot, Water Content, UV, Appearance, and pH.
  • Independently author and lead quality records such as Deviations, Lab Investigations, CAPA, Change Control including leading thorough and timely investigation and/or implementation activities.
  • Author and revise SOPs as needed.
  • Lead and/or support method development, optimization, transfer, qualification, and validation activities of analytical methods.
  • Support equipment and software qualification and maintenance activities.
  • Review of laboratory records generated in support of QC testing including procedures, methods, audit trails and other controlled documents.
  • Provide training to laboratory analysts as needed and guide junior analysts in the lab environment including troubleshooting.
  • Work on multiple projects to meet departmental and organization goals.
  • Work collaboratively with Manufacturing, QA and Regulatory to support CMC analytical deliverables.

Skills:    
Prefered Experience:
  • 3-4 years in a Quality Control laboratory environment (GMP environment) with a commercial setting.
  • Hands-on experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fisher and HPLC (SEC, IEX, HIC, RP, affinity).
  • Writing and or authoring deviations, lab investigations, protocols, SOPs, reports, and data trending.
  • Prior experience working in method validations, method transfers, Raw material and stability testing is a plus.
  • Must be able to maintain data integrity, and understanding of US and international (e.g. EU, ICH, GXP) regulations.
  • Ability to manage multiple tasks and meet deadlines with a high tolerance for ambiguity, solutions oriented and able to problem solve and identify root cause.

Education:    
  • Minimum Required:
  • BS in Biology, Chemistry or related Sciences.

Preferred:
  • Preferably in the pharmaceutical industry with knowledge of cGMPs is desired.






Pay Rate Range: $30-38/hr depending on experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Newark, CA

Explore exciting job opportunities in and around Newark, California! Situated in the heart of the San Francisco Bay Area, Newark offers an unbeatable blend of career advancement and quality of life. With easy access to Silicon Valley and major tech companies, as well as the cultural delights of nearby Berkeley and Oakland, this area is a magnet for innovative professionals. Enjoy the stunning views from Mission Peak Regional Preserve, indulge in diverse cuisines along the Niles Canyon Railway, catch a show at the Fremont Center for the Arts, or cheer on the San Jose Earthquakes soccer team at Avaya Stadium. Discover why Newark, CA is the perfect place to grow your career and explore new horizons!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.