Transdermal Operator II - 12 Hour Schedule - Night Shift

The Transdermal Operator II (3rd Shift) responsibilities include equipment start-up, participation in ANDA batch production and commercial batch manufacturing. Primary responsibilities include in-process checks and operating transdermal machines.

Essential Functions:
- Perform equipment set-up, IQ/OQ/PQ, and commercial batch activities; monitor automatic and semi-automatic equipment.
- Operate complex machines (e.g., Delta) to conduct mixing, coating, converting, pouching, and cartoning.
- Set up, run, and clean equipment in a GMP compliant environment.
- Troubleshoot and resolve manufacturing issues.
- Report issues/concerns to the department Supervisor that may impact successful batch execution.
- Immediately notify the department supervisor of any action/activity violating cGMPs, SOP, or safety procedures.
- Ensure prompt and accurate completion of processing equipment/room/scale/environmental log books.
- Maintain 100% documentation accuracy on GMP documents (batch records, log books, training records, in-process forms).
- Conduct R&D and commercial scale-up activities; follow cGMPs/SOPs/OSHA/regulations.

Additional Responsibilities:
- Other duties as assigned.

Qualifications:
- High School or GED (Required)
- 3 years manufacturing or GMP environment (Required); 3 years pharmaceutical manufacturing (Preferred)

Skills:
- Advanced English communication
- Advanced math and mechanical skills
- Advanced computer/data entry skills
- Advanced teamwork
- Advanced attention to detail and documentation practices

Specialized Knowledge:
- Strong knowledge of converting (die cutting) and packaging

Additional Requirements:
- Flexible to work extended hours when required
- Successful completion of an OSHA-compliant Respirator Fit Test

Schedule: 12-hour rotating schedule, 6:00 PM to 6:30 AM.