Position may be filled at either the N4 or N5 level depending on qualifications of the selected applicant.  The position will be in either the Raw Materials, Network Product Testing, Site Product Testing, Environmental Monitoring/Microbiology, or Lab Support Quality Control group and may require off-shift and weekend work schedule.

Main Purpose of the Position:

Perform analytical, biochemical, and/or biological testing; data review; and/or related activities that support QC laboratory operations.

Job Duties/Responsibilities:

• Perform testing of routine and non-routine samples 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.

• 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 customers to support operational activities.

• Support internal and external audits.

• Work to meet schedules.

• Identify and support resolution of technical problems.

• Actively participate in group and project teamwork; project and process improvements.

• Drafts protocols and reports under supervision.

• Meets scheduled performance of 95% on time.

• Perform other duties as requested by managers to support Quality activities.

Qualifications: Education, Experience, Knowledge and Skills:

• B.S./B.A. degree (preferably in relevant scientific discipline) and zero to three years of experience or an equivalent combination of education and experience.

• Basic knowledge of scientific theories, principles, and techniques used in analytical or biological test procedures.

• Ability to exercise sound judgment, reasoning, and problem solving.

• Capable of working under moderate supervision and determining own short term priorities.

• Capable of completing assigned responsibilities and keeping manager informed of status.

• Strong verbal and written communication skills, ability to organize and present information both formally and informally.

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.