Senior Analyst, Quality Control Analytical 12-month Contract Onsite in Novato, CA Must be able to work on a W2
SUMMARY The QC Analytical Senior Analyst, under minimal supervision, is responsible for the timely completion of lot release, stability, and non-routine testing of pharmaceutical drug substances and drug products while adhering to cGMP guidelines and procedures.
RESPONSIBILITIES • Performs, under minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines • Works independently on assays they have mastered • Develops and maintains proficiency in a broad range of test methods • Develops a technical understanding of each assay and assists with trouble shooting and laboratory investigations • Evaluates data against defined criteria/specifications • Actively applies knowledge in non-routine situations using a thorough understanding of the work processes and practices • Identifies key issues in complex situations, analyzes problems, and makes sound decisions • Assists in the revision of written procedures, method/equipment validation, and/or method transfers as assigned • Mentors and trains other analysts, including new hires and more junior analysts, in areas of expertise • Holds self and others accountable for adherence to department and company policies and practices • Maintains a safety and quality focused culture
EXPERIENCE • B.S./B.A. in Science (Major in Chemistry, Biology, Biochemistry). • 3+ years of experience in a cGMP/GLP laboratory • 2+ years hands-on experience in separation sciences (HPLC, UPLC, CE) • Ability to follow written instructions and to perform tasks with direct or minimal supervision • Strong leadership skills demonstrated through past work history • Use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel • Good written and verbal communication skills • Attention to detail and strong documentation skills • Ability to contribute effectively in team environments and independently • 3-5 years of Quality Control laboratory experience preferred • 3-5 years of hands-on experience in separation sciences (HPLC, UPLC, CE) preferred