Job Description
Job Description
Position is Temp to Perm: Must commit to 3 months temp and will be converted.
Shift:
- Must be able to rotate shifts every two months (from 1st to 2nd/3rd)
Must Haves:
- Chemical Operations or API experience within a Pharma Mfg. space
- Solid understanding of GMP and FDA regulations
- Must be able to rotate shifts every two months (from 1st to 2nd/3rd)
- Forklift experience but will not operate during contract period - after perm
Core Responsibilities:
- 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
- Maintain the facility in excellent FDA/cGMP posture
- Responsible for safety equipment and active participation in safety program and hazard analysis.
- Wears appropriate PPE for task.
- Ensure that waste is appropriately characterized, labelled, stored and disposed in compliance with all Company, state and federal regulations. Works collaboratively with Environmental, Health & Safety, as appropriate.
- Assure all production/support equipment is in proper operating condition and that all production equipment is appropriately labelled with a current status tag. Works collaboratively with Maintenance, as appropriate.
- Ensure the security and safe handling of all controlled substances at all times.
- Strictly adheres to all Company and DEA regulations.
- Ensure a level of housekeeping appropriate for a pharmaceutical manufacturer and maintain 5S areas.
- Active member of Emergency Response Team. Participate in Emergency Response Training and related activities.
- Promote a positive work environment by maintaining a safe work area and ensuring that their team members have the knowledge, skills and appropriate tools to perform their assigned duties and a thorough understanding of their performance expectations.
- Provide prompt, appropriate feedback to team members, both positive and constructive, in a continuing effort to develop employees to their full potential.
- Demonstrate a professional and positive attitude, integrity and a strong work ethic and encourages team members to do the same.
- Cooperate with all root cause investigations and follow corrective actions and compliance with Company policies and procedures, and all state and federal regulations occurs within department.
- Operate machines and equipment that involves set up and making adjustments to regulate temperature, pressure, flow and reactions or materials safely and in accordance with batch record and work instructions.
- Basic batch processing and unit operations, able to run all milling operations.
- Thinking is within well-defined procedures with assistance readily available.
- Proficient in all tasks/unit operations associated with a processing area ? Able to complete basic mechanical work required to keep operation moving
- Complex batch processing and unit operations, such as hydrogenations, PFD operations etc.
- Resolve regular technical problems and takes action to ensure the production plan continues to move