QC Scientist I

ALK-Abello, Inc•Post Falls, ID

3d•$58,000 - $64,000•Onsite

About The Position

ALK Source Materials, Inc., a leading manufacturer of quality allergenic biological source materials, and a member of the global ALK-Abello' group of companies, is recruiting for open QC Scientist I position. 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. Other responsibilities include authoring scientific documents such as SOPs, data trending reports, laboratory investigations and hypothesis reports; participating in analytical methodology transfers internally and externally as needed; accurately recording and reporting both qualitative and quantitative data. QC Scientists are also required to maintain appropriate documentation as directed by cGMP and qualification and calibration activities related to analytical laboratory equipment. This QC Scientist will be responsible for collecting and maintaining data using laboratory instruments and computers. The position will also assist the Validation Department with assessments of laboratory computer systems and equipment, equipment repair and preventative maintenance. Experience with SAP and/ or Sample Manager LIMS is preferred. The successful candidate will have a 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. All positions at ASM require the ability to work safely with insect venoms, allergens, hazardous chemicals and other laboratory reagents using appropriate PPE. All positions at ASM require the ability to comfortably and safely work around insect venoms, allergens, hazardous chemicals, solvents and other laboratory reagents.

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.
Demonstrated ability to analyze and interpret data and make conclusions accordingly.

Nice To Haves

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

Responsibilities

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.
Performing aseptic microbiology tasks and plate reading.
Source material identification using microscopy methods.
Water purity analysis.
Environmental monitoring.
Authoring scientific documents such as SOPs, data trending reports, laboratory investigations and hypothesis reports.
Participating in analytical methodology transfers internally and externally as needed.
Accurately recording and reporting both qualitative and quantitative data.
Maintaining appropriate documentation as directed by cGMP.
Performing qualification and calibration activities related to analytical laboratory equipment.
Collecting and maintaining data using laboratory instruments and computers.
Assisting the Validation Department with assessments of laboratory computer systems and equipment.
Assisting with equipment repair and preventative maintenance.
Working safely with insect venoms, allergens, hazardous chemicals and other laboratory reagents using appropriate PPE.
Comfortably and safely working around insect venoms, allergens, hazardous chemicals, solvents and other laboratory reagents.