Responsibilities:
- Lead other operators during execution of batches and equipment qualifications.
- Execute production schedule; ensure equipment/material availability.
- Assist supervisor with resolving issues; determine root cause and provide solutions.
- Review potential issues/concerns impacting successful batch outcomes and notify supervisor.
- Monitor line and notify supervisor of any violations of cGMPs, SOPs, or Safety, and any factors impacting product safety/strength/efficacy.
- Perform equipment set-up, IQ/OQ/PQ, and commercial batch activities.
- Monitor automatic and semi-automatic equipment to manufacture transdermal products.
- Complete equipment/room/scale/environmental log books accurately; record all activities.
- Partner with Technical Writer to generate equipment SOPs (set-up, operation, cleaning).
- Monitor operator actions for batch record compliance.
- Execute commercial validation batches per SOPs; ensure 100% documentation accuracy (batch records, log books, training records, in-process forms).
- Operate complex machines and SOPs for transdermal mixing, coating, converting, pouching, and cartoning.
- Set up, run, and clean equipment in GMP-compliant environments.
- Support R&D and commercial scale-up activities; train new personnel on SOPs and equipment.
Qualifications:
- Education: High School or GED (Required).
- Work Experience: 5+ years related experience in manufacturing/GMP environment (Required).
Skills/Abilities:
- English comprehension/communication; perform repetitive tasks (Advanced).
- Strong math and mechanical skills; computer systems/data entry (Advanced).
- Flexibility for extended hours (Advanced).
Specialized Knowledge:
- Thorough understanding of processing equipment in Transdermal Department.
- Expertise in converting (die cutting) and packaging.
Additional Requirement:
- Successful completion of an OSHA-compliant Respirator Fit Test (Required).
Compensation/Benefits (as stated):
- $27.00β$35.00/hour; short-term incentive/bonus opportunity within first 12 months; comprehensive benefits including health/insurance and 401(k) matching.
Schedule:
- Day shift: 12-hour rotating schedule (6:00amβ6:30pm), 3 days week 1 and 4 days week 2 of pay cycle; every other weekend required.