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Quality Control Analyst I
2 months ago
Company DescriptionLGC Clinical Diagnostics Business Unit is comprised of LGC Clinical Diagnostics, Inc. (formerly SeraCare Life Sciences & Maine Standards), Technopath Clinical Diagnostics, the Native Antigen Company, LGC Proficiency Testing & Thistle QA. Our 400+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), an ISO 9001- accredited facility in Oxford, UK and ISO 17043 facilities in Michigan (USA) and Johannesburg, South Africa. LGC Clinical Diagnostics is owned by LGC Group, a UK-headquartered life sciences measurement and testing business with >$510m of annual revenue and >3,500 employees globally.Job DescriptionThe Quality Control Analyst I will support manufacturing activities, perform routine laboratory maintenance, and conduct routine sample preparations and analyses. Work environments will include typing/computer work at a desktop workstation, sitting and/or standing at laboratory bench, and working in biosafety cabinets and chemical exhaust hoods. Key Responsibilities:
Support product dispense and kitting operations as necessary:
Verify fill weight and cap tightness of dispensed liquid product.
Verify correctness of applied product labels.
Maintain laboratory and equipment according to standard operating procedures.
Prepare samples for submission to external laboratories as required.
Conduct analyses of finished and intermediate products and raw materials according to standard operating procedures, including:
Immunoassays - ELISA, Dot Blotting and Immunohistochemical staining.
Nucleic acid extractions, quantitation and PCR.
Wet chemistry - pH, conductivity and spectrophotometry.
Review data for compliance to specifications and report non-conformances.
Prepare data and documentation to support product release.
Exercise Good Laboratory Practices and maintain data integrity and traceability.
Support overall company policies and procedures.
QualificationsKnowledge and Technical Skills:
Competent with basic laboratory equipment, pipetting and preparation of dilutions.
Analyses and proofreads results for validity and accuracy.
Maintains documentation for traceability.
Exercises judgement within generally defined practices and policies.
Proficient in written and verbal communication, including the ability to communicate technical issues in a clear, concise manner.
Ability to work independently or in a team, as the situation demands.
Flexibility to adapt to changing priorities, as required.
Education and/or Experience:
Requires a Bachelor's degree in a scientific discipline or equivalent with a minimum of 1 - 3 years of relevant experience.
Hands-on experience with immunoassays (ELISA, protein immunoblotting) is preferred.
Working experience in a regulated laboratory environment (GLP/GMP) is a plus.
Additional InformationPhysical Requirements:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical demands are normal for a laboratory/office environment as defined below.Working Conditions: • Work environment - Primarily an office/lab/warehouse/workshop setting with manufacturing exposure. • Extreme Conditions - The noise level in the work environment is usually moderate. • Protective Clothing Required - Steel-toe shoes, hearing or eye protection may be required.• Potential injuries or illnesses - will work in a biosafety level 2 environment and will be required to work with potentially infectious pathogens and human source materials, but with appropriate lab or personal protection.• Handling of hazardous waste - employee receives initial hazardous waste management training when hired to a position that requires managing hazardous waste. Annual refresher training is provided every year he or she remains in that position.• Work environment involves exposure to hazards or physical risks, which require following safety precautions and specific personnel training for employees working with hazardous materials and hazardous waste.All your information will be kept confidential according to EEO guidelines.
