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Sr. QC Analyst

Compass Consulting

Novato, CA

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JOB DETAILS
SKILLS
Analysis Skills, Assays, Biochemistry, Biotech and Pharmaceutical, Communication Skills, Current Good Manufacturing Practice (cGMP), Documentation, Drug Products, Equipment Validation, Genetic Diseases, Identify Issues, Mentoring, Physical Chemistry, Presentation/Verbal Skills, Problem Solving Skills, Quality Assurance Methodology, Quality Control, Record Keeping, Regulations, Safety/Work Safety, Specimen Analysis, Staff Development, Time Management, Training/Teaching, Writing Skills
LOCATION
Novato, CA
POSTED
30+ days ago
Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

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. The Senior Analyst works independently on assays they have mastered and performs advanced assays for multiple products. Work assignments will encompass performing and documenting activities and requires the ability to recognize deviations from approved procedures. Good record keeping, organizational, and written and verbal communication skills are essential. The Senior 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.

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

About the Company

C

Compass Consulting

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