What are the responsibilities and job description for the Pharmaceutical Manufacturing Team Lead position at Coda Search│Staffing?
Job Summary:
We are seeking a highly skilled Pharmaceutical Manufacturing Lead to oversee the production of high-potency APIs in our kilogram-scale lab. As a key member of our team, you will be responsible for ensuring that all products meet customer and internal specifications while maintaining excellent FDA/cGMP posture.
Key Responsibilities:
- Assist in executing Quality and Safety inspections, trainings, and programs for the Production group.
- Collaborate with SMEs in Safety, Quality, Maintenance, Training, etc. to translate objectives to Production.
- Complete batch records in accordance with FDA and Current Good Manufacturing Practices (cGMP) guidelines.
- Provide process support and troubleshooting necessary to meet all customer requirements.
Requirements:
- High School Diploma with 5-10 years of experience in highly potent API Manufacturing or equivalent.
- Solid understanding of GMP and FDA regulations.
- Excellent communication and safety awareness skills.
- Ability to independently apply scientific and/or technical knowledge in the performance of job duties.
Working Conditions:
- Walking, standing for long periods of time while in plant, reaching, handling, twisting, and bending spine at waist when operating equipment.
- Able to lift 50lbs.
- Must be willing to work a rotating shift.
