QC Stability Associate I

Job Description

Position Summary

Participate in stability programs and perform testing of stability samples. The QC Stability Associate conducts all work under the general supervision and direction of the QC Stability Manager.

Duties and Responsibilities

Perform laboratory testing of finished product, in-process, and stability samples

Create and revise documents related to testing such as SOPs, test methods, protocols, and reports

Author and revise quality control procedures and specifications as necessary

Calibrate laboratory instrumentation

Perform laboratory maintenance activities such as temperature checks, ordering laboratory supplies, cleaning, and disposal of laboratory waste

Prepare shipments of samples to contract testing laboratories and interfacing with outside laboratories

Pull stability samples from appropriate storage as outlined in Stability Protocols

Ability to work unscheduled and overtime hours as needed.

Other duties as assigned

Regulatory Responsibilities

Work in compliance with OSHA, FDA, 21 CFR 820, 21 CFR 210 and 211, and other regulatory agency requirements applicable to quality operations, safety and compliance

Supervisory Responsibilities

N/A

Experience

Prior experience working in a cGMP laboratory environment preferred

Education

Bachelors’ in Biology, Microbiology, Chemistry, and/or Physical Sciences

Knowledge, Skills & Abilities

Working knowledge of testing techniques, principles, and basic laboratory instruments including pH meter, balance, spectrophotometer, and CCIT instrumentation.

cGLP and cGDP

Perform routine work instructions under general supervision

Resolve routine problems

Experience with Microsoft Office and general computer proficiency

Effective communication, both verbal and written

Competent in Technical Writing

Physical Requirements

Ability to remain stationary for prolonged periods of time

Ability to lift up to 25 lbs.

Satisfactory audio-visual acuity

Ability to walk between locations

Fine and gross motor skills to manipulate instruments