What are the responsibilities and job description for the QC Stability Associate I position at BERKSHIRE STERILE MANUFACTURING LLC?
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
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