Analyst, QC | Novato, CA

Overview

Great Opportunity || Analyst, QC I | Novato, CA

• Perform, under minimal supervision, physical, chemical, and biochemical analyses of incoming raw materials under cGMP to meet specified timelines. Evaluate data against defined criteria/specifications and maintain proficiency in a broad range of trained test methods. Responsibilities may include training technicians and other analysts in areas of expertise.
• Collaborate with co-workers to share general housekeeping activity assignments and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness. Evaluate results and trend data, maintain raw materials log, and control laboratory inventories. Coordinate and track outside laboratory testing activities and incoming samples from vendors for qualification purposes. Participate in the preparation of investigations, summaries, and reports.
• Must have a quality service attitude and be willing to work additional hours to meet production or laboratory requirements when necessary. On rare occasions, provide on-call coverage for Out of Specification conditions to support production testing and quality control laboratory equipment. Develop familiarity concerning cGMP, 21
  
  CFR, USP, EP, JP, and ICH regulatory requirements.
• Interact with other departments and assist in the revision of written procedures as assigned. Hold self and others responsible to abide by department and company policies and practices. Maintain the laboratory in an inspection-ready state and exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures. Initiate investigations within required time frames and perform other duties as assigned.

• Must have a positive, team-minded personality.
• Demonstrated working knowledge related to specific functional activities.
• Ability to perform most tasks with moderate supervision.
• Computer literacy is required; experience with Microsoft Word and Excel;
  Labware LIMS is a plus.
• Excellent record keeping, written, and verbal skills.
• Work in a GMP laboratory and be compliant with laboratory procedures.
• May work with biohazardous materials, hazardous chemicals, and radioactive materials.
• Comfortable lifting 50 pounds and able to work independently with multiple tasks.
• May be required to work second shift, overtime, weekends, and holidays; moderate supervision may be necessary for ad hoc assignments.
• Strong organizational skills and good written and verbal communication; must work effectively as a member of the Bio Marin team.
• Quality service attitude with willingness to work additional hours to meet deadlines and requirements.

• Experience in a cGMP laboratory; quality control experience beneficial.
• Experience in quality control practices, current Good Manufacturing Practices, or Good Laboratory Practices.
• Familiarity with Compendial testing (USP, EP, JP).
• Familiarity with complex instrumentation (HPLC, GC).
• Familiarity with Labware LIMS.

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Full-time
• Job function:
  Other
• Industries: IT Services and IT Consulting