Responsibilities

Completes GMP documentation per applicable SOPs and protocols in order to maintain compliance with health and safety and regulatory requirements as written.

Participate in QC Laboratory operations including laboratory equipment maintenance, laboratory reagent, and inventory management, logbook review, sample management and training.

Participates and performs cross-training to support staff availability within QC.

Develops expertise in assigned areas.

Revises and participates in drafting SOPs and technical reports.

Manages the maintenance logs of scientific equipment and instrumentation.

Supports ongoing stability programs and data entry.

Performs other duties as assigned.

Qualifications

Bachelor’s degree in a Scientific discipline is required. 1-2 years' experience with GMP facilities (equipment/samples) required. QC background preferred.

Laboratory experience is preferred, preferably in an aseptic processing facility.

Experience with GMPs, safety regulations, and data integrity.

Good understanding and demonstration of aseptic techniques.

Proficient in MS Word, Excel, PowerPoint, and other applications.

Comfortable and able to adjust workload based upon changing priorities.

Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of the initial job description.

Ability to think critically and demonstrate troubleshooting, and problem-solving skills.

Excellent interpersonal, verbal, and written communication skills.