Analyst 1, QC Compendial Testing

Position overview

What you’ll do

• Support material life-cycle management, including assessment of new materials and establishment and maintenance of specifications, under supervision.
• Support internal technology-transfer meetings for new products and assist the QC Manager with implementation of new technologies.
• Author and review procedures, protocols, reports, and specifications related to compendial testing of materials under supervision.
• Test and disposition incoming raw materials and components according to specifications and procedures, meeting defined turnaround times.
• Execute change controls and vendor change notifications arising from partner, internal, or compendial needs.
• Initiate and implement TrackWise deviations and invalid assays, corrective and preventive actions, and laboratory exceptions.
• Conduct routine investigations supporting out-of-specification test results and help maintain effective laboratory systems.
• Follow established policies and procedures, review updated specifications, and escalate opportunities to improve daily work.
• Use safety data sheets to assess chemical hazards, spill response procedures, and personal protective equipment requirements.

Knowledge, skills, and abilities

• Computer proficiency, effective problem solving, attention to detail, and strong interpersonal skills.
• Able to work in a fast-paced environment, complete tasks independently or with guidance, and communicate effectively in writing and verbally.
• Self-driven, flexible, and collaborative.

Minimum qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Biochemistry, or a related scientific discipline, with 0–1 years of applicable industry experience.
• Basic understanding of GMP, GLP, and GDP requirements.

Preferred qualifications

• A master’s degree in a relevant scientific discipline with 0 or more years of experience, or 1–3 years of relevant experience, is preferred.
• Familiarity with compendial testing methodology in a cGMP setting, assay troubleshooting and problem solving, and GMP-environment experience are preferred.

Physical requirements