Quality Control Scientist II

About the role

Join our stable and growing company and provide leadership and expertise to our workforce located in our 150,000 square foot facility in Post Falls, ID. The QC Scientist is responsible for performing release and stability testing of source materials, including protein profile (SDS-PAGE, Native PAGE), Western Blot, allergen potency (major and total allergen activity by ELISA and RID), total protein (BCA and Lowry), GC, Karl Fisher (volumetric and coulometric), LOD, FTIR, with limited input from supervisor. Analysts may also perform aseptic microbiology tasks and plate reading, source material identification using microscopy methods, water purity analysis, and environmental monitoring.

Responsibilities

• Perform release and stability testing of source materials, including protein profile (SDS-PAGE, Native PAGE), Western Blot, allergen potency (major and total allergen activity by ELISA and RID), total protein (BCA and Lowry), GC, Karl Fisher (volumetric and coulometric), LOD, FTIR, with limited input from supervisor.
• Perform aseptic microbiology tasks and plate reading.
• Identify source materials using microscopy methods.
• Perform water purity analysis and environmental monitoring.
• Author scientific documents such as SOPs, data trending reports, laboratory investigations and hypothesis reports.
• Participate in analytical methodology transfers internally and externally as needed.
• Accurately record and report both qualitative and quantitative data.
• Maintain appropriate documentation as directed by cGMP and qualification and calibration activities related to analytical laboratory equipment.
• Collect and maintain data using laboratory instruments and computers.
• Assist the Validation Department with assessments of laboratory computer systems and equipment, equipment repair and preventative maintenance.

Requirements

• Bachelor's degree in Biology, Microbiology or Chemistry (or on track to graduate soon) or equivalent combination of training and relevant work experience in a highly regulated environment or laboratory setting.
• Hands-on experience and an understanding of common analytical and scientific methods and theory is required, along with demonstrated ability to analyze and interpret data and make conclusions accordingly.
• A working knowledge of Pharmaceutical quality systems such as FDA and EU cGMP and ICH Q10, and understanding of compendial requirements such as USP is highly preferred.

Qualifications

• The successful candidate must be able to work safely with insect venoms, allergens, hazardous chemicals and other laboratory reagents using appropriate PPE.

Skills

• Experience with SAP and/or Sample Manager LIMS is preferred.

Benefits

• 401K company contribution and matching
• Paid vacation
• Sick time
• Free catered lunches 2x a week
• On-site workout facilities
• Many other perks

Pay

Competitive salary commensurate with experience.

Schedule

Full-time position.