Quick overview
Job description
Duties & Responsibilities
- Strictly follows standard operating procedures (SOP).
- Complies with Good Manufacturing Practice (GMP).
- Completes documentation, including logbooks, batch records, and quality records.
- Maintains an organized, clean, and stocked production area.
- Cleans tools, rooms, and equipment after use.
- Weighs, measures, subdivides, and disposes of product components.
- Safely handles and disposes of hazardous materials.
- Operates specialized machinery to manufacture pharmaceutical products under supervision.
- Works closely and communicates effectively with operations team.
- Performs other related duties as assigned.
Required Skills & Knowledge
- Mechanical aptitude.
- Strong verbal and written communication skills.
- Strong organizational skills and attention to detail.
- Proficient in basic math.
- Strong time management skills with ability to meet deadlines.
- Ability to prioritize and ask for assistance to delegate tasks when appropriate.
- Ability to focus in a fast-paced environment with shifting priorities.
- Proficient with Microsoft Office Suite or related software.
Education & Experience
- High School Diploma or equivalent.
- Coursework or experience in chemistry or manufacturing field preferred, but not required.
- Operations Specialist require a minimum of 1 year of GMP experience within pharmaceutical manufacturing
Physical Requirements
- Prolonged periods of sitting or standing while monitoring equipment.
- Must be able to lift up to 25 pounds regularly, and up to 55 pounds occasionally.
- May require ability to work swing or weekend shift with the possibility of 12-hour shifts.
- Must be able to wear a Tyvek suit with PAPR for extended periods of time.
- Exposure to constant low-level equipment noise, and occasional high-level alarms.
- Work near heat generating equipment.
- Must be able to operate a forklift, training provided.
- Move up and down ladders, kneel, squat, balance on one foot.
- Move mop above head while cleaning room surfaces.
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