What are the responsibilities and job description for the Manufacturing Associate position at Harba Solutions Inc.?
Key Responsibilities:
- Perform all activities associated with the manufacturing process, including setup, operation, and maintenance of production equipment and isolators.
- Ensure compliance with safety, environmental, and quality regulations while maintaining focus on key performance goals.
- Complete required training programs covering Standard Operating Procedures (SOPs), aseptic techniques, gowning, and health and safety practices.
- Support production readiness by cleaning and sterilizing work areas and equipment.
- Conduct environmental monitoring and ensure documentation accuracy throughout all production stages.
- Prepare and track all materials in alignment with established procedures and batch record systems.
- Maintain compliance with cGMP requirements and support investigations, audits, and validation activities as needed.
- Accurately complete and review all production records, logs, and related documentation.
Qualifications:
- Bachelor’s degree in a scientific or engineering discipline preferred.
- In lieu of a degree, at least 1 year of experience in a cGMP-regulated or aseptic manufacturing environment is required.
- Familiarity with FDA or other regulatory guidelines relevant to sterile production.
- Ability to work aseptically in a cleanroom (Grade C or equivalent) for extended periods.
- Must meet visual acuity standards (corrective lenses acceptable).
- Capability to lift or carry up to 35 pounds.
- Prior experience in pharmaceutical or radiopharmaceutical manufacturing is advantageous.