6558 QC Analyst I
With direct supervision, QC Analyst, is responsible for the performance of direct materials reagent preparation and some testing in accordance with cGMP regulations and the Company standards.
Perform a broad variety of basic and moderately complex reagent preparation and some testing with documentation according to GMP.
Review reagent prepared and assess against established acceptance criteria.
Identify and troubleshoot technical problems.
Identify gaps in systems and procedures.
Perform equipment maintenance.
Prepare and maintain standards, controls, stocks, cultures, etc. per established procedures.
Support the maintenance and compliance of operational areas.
Assure and apply GMP throughout operations.
Coordinate with customers to support multi-site operational activities.
Works to meet schedules, timelines, deadlines.
Participate in group and project teamwork; project and process improvements.
Meets scheduled performance of 95% on time.
Adheres to all safety regulations and actively contributes to the Company’s safety culture.
Perform other duties as requested by managers to support Quality activities.
B.S. /B.A. degree and one year experience or an equivalent combination of education and experience. Degrees are preferably in relevant scientific disciplines and experience is in the pharmaceutical or biopharmaceutical industry.
Good verbal and written skills.
Demonstrated ability to apply knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.
Routinely exercises sound judgment, reasoning and problem solving.
Capable of working under direct supervision and determining own short-term priorities.
Work Environment/Physical Demands/Safety Considerations
Physical requirements – Prolonged periods of standing at lab bench top. Frequent lifting (up to 10 lbs), bending, reaching, twisting. Use of step ladders and push carts required.
Position may involve use of reagents and other chemical compounds, including but not limited to acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.
Pass visual screening, as required.
Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.