Analyst, QC I

Intelliswift Software • Santa Clara, CA

82d

About The Position

The Analyst, QC I position involves performing physical, chemical, and biochemical analyses of incoming raw materials under cGMP to meet specified timelines. The role requires evaluating data against defined criteria/specifications and maintaining proficiency in a broad range of trained test methods. The analyst may also train technicians and other analysts in areas of expertise, collaborate with co-workers on laboratory maintenance, and evaluate results and trend data. Responsibilities include maintaining raw materials logs, coordinating outside laboratory testing activities, and preparing investigations, summaries, and reports. A quality service attitude is essential, along with the willingness to work additional hours when necessary. The position may also involve providing on-call coverage for Out of Specification conditions and developing familiarity with regulatory requirements such as cGMP, 21CFR, USP, EP, JP, and ICH.

Requirements

• 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 required; experience with Labware LIMS is a plus.
• Excellent record keeping, written, and verbal skills.
• Experience working in a GMP laboratory and compliance with laboratory procedures.
• Comfortable lifting 50 pounds.
• Ability to work independently and manage multiple tasks.
• Organizational skills and good communication skills are essential.

Nice To Haves

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

Responsibilities

• Perform physical, chemical, and biochemical analyses of incoming raw materials under cGMP.
• Evaluate data against defined criteria/specifications.
• Maintain proficiency in a broad range of trained test methods.
• Train technicians and other analysts in areas of expertise.
• Collaborate with co-workers on laboratory maintenance and housekeeping activities.
• Evaluate results and trend data.
• Maintain raw materials log and control laboratory inventories.
• Coordinate and track outside laboratory testing activities.
• Coordinate and track incoming samples from vendors for qualification purposes.
• Participate in the preparation of investigations, summaries, and reports.
• Exhibit proactive communication regarding compliance risks and deviations.
• Maintain the laboratory in an inspection-ready state.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree