Quality Control Analyst; HPLC Analytical Testing

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 requires the ability to recognize deviations from approved procedures.

Good record keeping, organizational, 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.

This is a 12-month contract based in Novato, California. Monday to Friday onsite schedule.

• 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 trouble shooting and laboratory investigations.
• 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.

• B.S./B.A. in Science in Chemistry, Biology, or Biochemistry.
• 1-2+ years of Quality Control laboratory experience.
• 1-2+ years of hands-on experience in separation sciences (HPLC, UPLC, CE).
• 1-2 + years of experience in a cGMP/GLP laboratory.
• 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 skill.
• Attention to detail and strong documentation skills.
• Ability to contribute effectively in team environments and independently.
• Equipment:
  Waters HPLC, Waters UPLC, Dionex HPLC, Sciex PA800, Protein Simple iCE3, UV/VIS Spectrophotometer, pH Meter.
• $64,771-$80,974

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance – PPO, HMO & HSA
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Online timecard approval

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.