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.
