6169 QC Analyst I
Description:
Supports routine and non-routine analysis, including but not limited to biochemical and chemical analysis, of raw materials, in-process items and finished product according to established operating procedures.
Compiles data for documentation of test procedures that may include stability program testing and formulation studies.
Calibrates and maintains lab and analytical equipment.
Participates in the preparation of investigations, summaries and reports.
Reviews data obtained for compliance to specifications and reports abnormalities.
Revises and updates standard operating procedures as needed.
May perform special projects on analytical and instrument problem solving.
May develop testing and analysis methods and procedures in accordance with established guidelines.
With moderate supervision, QC Associate I, is responsible for the performance of direct materials testing in accordance with cGMP regulations and the Company standards.
These duties include execution of laboratory testing, trend analysis, documentation review, support of discrepancies (OOS, OOT, OOE) and other laboratory support activities.
In conjunction with Quality Control leadership, the QC Associate I works to meet departmental and organizational goals.
Job Responsibilities
Perform a broad variety of basic and moderately complex tests with documentation according to GMP.
Review data and assess against established acceptance criteria.
Perform technical review of peer-generated data.
Evaluate data to identify trends and/or establish limits.
Identify discrepancies; provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as needed.
Identify and troubleshoot technical problems.
Identify gaps in systems and procedures.
Receive and provide training.
Participate in assay transfer and assay validation.
Perform equipment qualification / 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.
Support internal and external audits and regulatory inspections.
Works to meet schedules, timelines, deadlines.
Participate in and/or lead group and project teamwork; project and process improvements.
Write protocols and reports under limited supervision.
Meets scheduled performance of 95% on time.
Perform other duties as requested by managers to support Quality activities.
Job Requirements
B.S. /B.A. degree and two years experience or Master’s Degree plus one year experience or an equivalent combination of education and experience.
Degrees are preferably in relevant scientific discipline and experience is in pharmaceutical or biopharmaceutical industry.
Strong verbal and written communication skills, ability to organize and present information both formally and informally.
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 moderate 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.
Works to meet schedules, timelines, deadlines.
Participate in and/or lead group and project teamwork; project and process improvements.
Write protocols and reports under limited supervision.
Meets scheduled performance of 95% on time.
Perform other duties as requested by managers to support Quality activities.
PLEASE NOTE: 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.