Under close supervision, leads and performs a variety of processing duties according to batch record and Standard Operating Procedures (SOP's) in small scale manufacturing including, but not limited to, weighing, mixing, fabricating, coating and pouching/packaging. Essential functions include:
•Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.
- Ensures batch records, equipment log books, and other relevant records are current.
- Reports process or equipment problems to supervisor.
- Sets-up equipment for processing operations.
- Cleans and maintains processing rooms and equipment.
- Performs environmental surface swabbing as assigned.
- Monitors process and equipment and makes necessary adjustments to maintain batch record specifications.
- Performs IQ/OQ testing and qualifications.
- Follows established department SOP's and batch record instructions.
- Ensures project deadlines and performance standards are established and met.
- Ensures compliance with all Company policies and procedures, including safety rules and regulations.
- Performs related duties as assigned.
Six months to one (1) year experience in a pharmaceutical manufacturing environment.Knowledge of:
- Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.
- SOP's, equipment and safety practices.
- Manufacturing processes and equipment procedures.
- Business English usage, spelling, grammar and punctuation.
- Basic mathematical computations.
NOTE: Work hours - M, T, W, and every other Th from 6:00 a.m. - 6:30 p.m.
High School diploma or equivalent.