What are the responsibilities and job description for the Quality Control Analyst position at Lenox Executive Search?
Lenox Executive Search is seeking a Quality Control Analyst for a CONTRACT position with one of our global pharmaceutical clients. This a ONE-YEAR CONTRACT role fully onsite in Lexington, MA.
· Primary duties of this position will focus on the daily lab operations and execution
of testing to support manufacturing operations.
· Testing may include but not limited to
samples from drug substance and drug product, manufacturing, stability, raw materials
and various protocol studies using test methods.
· The assays range from pH, enzyme
concentration to more complex assays such as SDS silver Gels, PCR, DNA and enzyme
activity.
· This position is expected to maintain operational and GMP readiness of the QC
areas.
· In addition, this position will participate in more complex projects, Operational
excellence initiatives and various quality systems.
Specific QC Focus Area:
Biochemistry Focus: A280, SOLO A280, Compendial methods (pH. Moisture, OSMO,
Appearance, Subvisible particles), Enzyme Activity assays, DNA, PCR, Free Thiol
Responsibilities:
· 80% Testing execution
· 10% QC operations support which entails data review, data trending, OE/5S initiative, maintenance of equipment and reagents, reagent prep, lab housekeeping, support for other QC groups if needed.
· 10% Compliance and quality systems (SOP revisions, input to quality system
Education and Experience Requirements:
· Bachelor's degree and minimum of 0-2 years related experience
Desired: GMP knowledge, work experience
· Limited use and/or application of basic principles, theories and
concepts.
· Limited knowledge of industry practices and standards. Position requires
critical thinking.
MS Office, LIMS, SAP, Trackwise, EDMS, Compliance and strong science understanding
readily obtained. Builds stable working relationships internally.
Pay: $38.00 per hour
Work Location: In person
Salary : $38