Associate II, Manufacturing Operations (Saturday/Nights)
On-siteDanbury, Connecticut, United States
Job Summary
Execute quality and manufacturing procedures to produce intermediate, semi-finished, and finished pharmaceutical products meeting regulatory requirements. Operate production equipment, perform area setup, cleanup, and sanitization, and conduct in-process inspection and testing under supervision. Document all manufacturing activities in controlled records and verify steps performed by other associates. Assist with establishing operating specifications, standard procedures, and equipment maintenance, while observing all health, safety, and environmental guidelines in a clean room environment. Work every other Wednesday through Saturday from 6:00 pm to 6:30 am. Requires high school education, 3–5 years of related experience, and ability to wear a respirator and gown in three layers.
Required Qualifications
- High School/GED
- 3 - 5 years related experience
- willing and able to receive medical clearance to wear a respirator (i.e., Powered Air Purifying Respirator) for entire working shift
- physically able to gown and de-gown (including the use of a decontamination fogging shower) in up to three layers of clean room and potent compound facility gowning (i.e., Tyvek® jumpsuit)
- knowledge of regulatory environment requirements and/or compliance (including all applicable regulations i.e., FDA, ISO 13485, European requirements, etc.)
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.