About this role
Duties & Responsibilities
- Strictly follows standard operating procedures (SOP).
- Complies with Good Manufacturing Practice (GMP).
- Completes documentation, including logbooks, batch records, and quality records.
- Revises documents for improved compliance and ease of use.
- 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.
- Training with other inner department teams.
- SME on particular process or equipment; interfaces with vendors or clients.
- Works closely and communicates effectively with operations team.
- Involved in safety and process improvement plans.
- Responsibilities may increase in scope to align with company initiatives.
Requires Skills & Knowledge
- Proficient understanding of pharmaceutical manufacturing processes, requires minimal instruction.
- Self-motivated.
- Ability to instruct or train others.
- Mechanical aptitude.
- Strong verbal and written communication skills.
- Strong organization 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.
- Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the company.
- Demonstrated ability to collaborate and work in cross-functional teams.
- Ability to focus in a fast-paced environment with shifting priorities.
- Proficient with Microsoft Office Suite or related software.
- Accepts feedback from a variety of sources and constructively manages conflict.
Education & Experience
- High School Diploma or equivalent.
- Coursework or experience in chemistry or manufacturing field preferred.
- Approximately 2 years of GMP experience.
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.
- Move up and down ladders, kneel, squat, balance on one foot.
- Move mop above head while cleaning room surfaces.
- Adheres to consistent and predictable in-person attendance.