Quick overview
Job description
Duties and Responsibilities
- Oversee small production team and daily shift activities
- Follow strict standard operating procedures (SOPs)
- Write and review standard operating procedures
- Weighs, measures, subdivides, and disposes of components
- Safely handle hazardous materials
- Participate in audits or inspections
- Inspects and maintains equipment
- Draft, review, and approve quality records as technical approver
- Subject matter expert for operations
- Conduct and attend training activities
- Completes documentation, including logbooks and batch production and control records
- Works closely and communicates effectively with operations team
- Responsibilities may increase in scope to align with company initiatives
- Performs other related duties as assigned
Required Skills and Abilities
- Mechanical aptitude
- Intermediate math skills
- Strong verbal and written communication skills
- Strong organization skills and attention to detail
- Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside of the company
- Accepts feedback from a variety of sources and constructively manages conflict
- Proficient math and problem-solving skills
- 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 and Experience
- High school diploma or equivalent
- Demonstrates history of leadership abilities
- Proficient in Oral Solid Dosage and Spray Dry equipment and GMP processing
- Requires a minimum of 2 year 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
- Require ability to work swing 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 and lift from the floor
- Move mop above head while cleaning room surfaces
- Adheres to consistent and predictable in-person attendance
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