Job Description
The Process Operator will micronize and mill client-provided materials, including active pharmaceutical ingredients and excipients, following company procedures, policies, client instructions, and cGMP guidelines. The role models company values and leadership behaviors in all interactions.
Operator Responsibilities:
1. Perform entry-level micronization and milling of hazardous and non-hazardous pharmaceutical actives and excipients.
2. Set up, operate, and monitor production equipment and processes.
3. Document production details accurately on batch records, following good documentation practices (GDPs).
4. Work in a regulated environment, adhering to SOPs and policies.
5. Maintain compliance with cGMP standards.
6. Identify and communicate non-routine events, deviations, and GMP deficiencies promptly to supervisors.
7. Clean processing areas and equipment thoroughly.
8. Produce clear, consistent documentation in line with quality standards: attributable, legible, contemporaneous, original, and accurate.
9. Show willingness to learn, adapt to change, and work with new processes.
10. Ask questions or suggest improvements when necessary.
11. Participate in shift change meetings, team meetings, email correspondence, and project activities.
12. This is a site-based position.
13. Strive for First Time Right (FTR) to meet annual KPIs.
14. Stay current with site training via Compliance Wire and other platforms.
15. Perform additional duties as assigned by management.
Performance Measures:
* Adherence to safety and quality procedures.
* Product quality, throughput, and yields.
* Attendance, punctuality, and dependability.
* Work ethic and attitude towards daily operations.
Position Requirements:
Education or Equivalent:
High School Diploma or GED.
Experience:
* Dependable, eager to learn, able to meet physical job requirements.
* Preferred prior manufacturing and regulated environment experience.
* Ability to work weekday and weekend overtime is a plus.
Knowledge/Skills:
* Strong oral and written communication skills.
* Basic math skills and interpretation.
* Potential exposure to hazardous chemicals; proper PPE must be worn.
* Experience with production equipment is preferred.
Physical Requirements/Work Environment:
* Physical strength, stamina, and dexterity, including working in fully enclosed air suits.
* Ability to lift/move up to 44 lbs. alone, with assistance for heavier loads.
* Work safely with high-potency APIs and novel compounds.
* Perform physical tasks such as lifting, climbing, bending, crouching, reaching, and twisting.
* Stand or walk for up to 8 hours.
* Work at heights and in loud environments with hearing protection.
* Handle chemicals safely per safety protocols.
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