3947 QC Analyst I
Perform testing of routine and non-routine samples and document according to GMP.
Perform environmental monitoring and utilities sampling and document according to GMP.
Review data and assess against established acceptance criteria.
Perform technical review of peer-generated data for basic methods.
Prepare data tables and graphs Identify discrepancies, participate in quality investigations and CAPA (corrective actions preventive actions) initiatives as needed.
Receive and provide training.
Participate in assay transfer and assay validation as needed.
Perform equipment qualification/maintenance.
Prepare and maintain standards, controls, stocks, and cultures per established procedures.
Support the maintenance and compliance of operational areas.
Assure and apply GMP throughout operations.
Coordinate with supplier/customers to support operational activities.
Support internal and external audits.
Work to meet schedules.
Identify and support resolution of technical problems.
Resolve sample issues as needed.
Actively participate in group and project teamwork; projects and process improvements.
Draft protocols and reports under supervision.
Meets scheduled performance of 95% on time (ATS).
Perform other duties as requested by managers to support Quality activities.
Ability to write clearly and effectively.
Good verbal communication skills.
Basic knowledge of scientific theories, principles and techniques used in analytical or biological test procedures.
Ability to exercise sound judgment, reasoning and problem solving with general guidance.
Capable of completing assigned responsibilities and keeping manager informed of status.
Ability to work off-shift, weekends and holidays as needed.
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 compound.
Must be physically able to perform the following tasks: Work in a laboratory environment including biosafety cabinets.
Able to lift up to 25lbs. Sit, stand and move within work space for extended periods.
B.S./B.A. degree (preferably in relevant scientific discipline) or an equivalent combination of education and experience.