Job Details

Are you an experienced QC Analyst with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced QC Analyst to work in Novato, CA.

Position Summary: The QC Analytical 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. The Analyst works independently on assays they have mastered and performs advanced assays for multiple products. Work assignments will encompass performing and documenting activities and require the ability to recognize deviations from approved procedures. Good record keeping, organisational, and written and verbal communication skills are essential. The Analyst is expected to demonstrate strong cGMP and compliance acumen, become a subject matter expert for regulatory inspections, and provide training and educational development of other staff.

Primary Responsibilities/Accountabilities:

• Performs, under minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines. General cGMP lab experience at the Analyst level.
• 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 troubleshooting 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

Qualifications:

• B.S./B.A. in Science (Major in Chemistry, Biology, Biochemistry).
• 1-2 + years of experience in a cGMP/GLP laboratory
• 1-2+ 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

Preferred:

• 1-2+ years of Quality Control laboratory experience
• 1-2+ years of hands-on experience in separation sciences (HPLC, UPLC, CE)