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13 Jul 2023
Full-Time Operator I, Production (2nd Shift)
Job Description
The incumbent is responsible for the execution of all aspects of parenteral manufacturing which includes, but is not limited to, the aseptic filling/lyophilization, compounding, component preparation, terminal sterilization of diluent product and in-process control of sterile pharmaceuticals. The incumbent interacts with QC, QA, Tech services, Maintenance, IT, Materials Management, Product Development and other departments as required. This position is a 2nd shift assignment.
- Assist production management in coordinating process activities to assure efficient, timely and smooth operations.
- Become proficient at set up, operation of and assessing/resolving minor equipment mechanical problems of all equipment in the Controlled Classified Production areas (A/B, C, D) including but not limited to stopper processor, vial washer, tunnel, capper, filler, autoclaves, VHP pass-thru, small parts washer/dryer and lyophilizer.
- May provide general or direct supervision to non-exempt employees. A portion of the time may be spent performing individual tasks.
- Adhere to cGMPs, SOPs, Batch Record Processing Steps and site safety policies.
- Assist supervision with SOP development and review.
- Review manufacturing batch records.
- Cross train as packaging operator and sanitization technician in order to provide backup if needed.
- Perform other duties as assigned.
Qualifications
- Associates and/or Bachelor’s degree preferred or combination of education and work related experience.
- Preferred pharmaceutical industry or related experience.
- Demonstrated effective communicating and interpersonal skills.
- Previous experience working in controlled critical areas (Grade A/B, C, D or ISO5, 7, 8).
- Excellent written and communication skills.
- Ability to stand on feet for up to four hours at a time.
- Be able to lift, push, and /or pull up to 25 pounds.
- Be able to independently gown for aseptic processing.
- Meet minimal visual acuity requirements necessary for quality assessments in a production or packaging environment.
- Be able to be medically cleared to wear full face tight fitting respirator based on OSHA Respiratory Protection Standard.
- This position requires oversight in GMP areas (Grade A/B, C and D) within the Parsippany manufacturing facility and the incumbent must demonstrate an ability to enter these GMP areas by passing established gown qualifications.
Additional Information
All your information will be kept confidential according to EEO guidelines
How to Apply
Click here to apply| https://smrtr.io/fDWPk |
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