QC Analyst (I or II)
Working within FDA cGMP regulations, perform testing for release and stability of intermediate product/starting materials, drug substance and drug products. Generate and record testing results accurately and documented per applicable regulatory and SOP requirements. Troubleshoot equipment problems. Write and revise Standard Operating Procedures as appropriate to laboratory operations and laboratory compliance. Participate in method validation and method transfer activities. Experiences in HPLC and GC are required.
• Perform release and stability testing according to SOPs and in compliance with cGMP regulations and guidelines.
• Maintain meticulous laboratory notebook documentation of testing.
• Data analysis using Microsoft Excel and application software, e.g. Waters Empower.
• Accurately enter data into Stability Laboratory Information Manager database.
• Maintain cGMP compliance in the laboratory.
• Write, revise and/or review Standard Operating Procedures.
• Maintain extensive knowledge of Standard Operating Procedures and GMP regulations and guidelines.
• Troubleshoot equipment problems.
• Other duties may be assigned.
Education & Qualifications
• BS or MS in Chemistry/Biochemistry, Biology or related field
• 2-5 years experience in pharmaceutical industry, preferably in QC
• Good computer skills, PC
• Excellent written and verbal skills
• Ability to work independently and manage multiple analyses
• Knowledge of cGMPs related to QC operations
• Instrumentation knowledge (HPLC, GC, UV/Vis, NMR, FTIR)
• Wet Chemistry
• Experience with Waters Millenium/Empower chromatography data software
• Knowledge & experience in HPLC and GC
• Basic understanding of cGMP, GLP and SOPs
• Recognize atypical and out of specification results, instrument malfunctions, and methodology issues and participate in the investigation process
• Medical, Dental, and Vision Insurance
• 401K Plan with Company Match
• Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.