Production Specialist

3 weeks ago


North Andover, Massachusetts, United States Veranova L P Full time

Veranova L P seeks a highly skilled Production Specialist to join their team in API manufacturing.

Job Summary:

  • To manufacture bulk API pharmaceuticals in accordance with customer and internal specifications.
  • Complete batch records in accordance with FDA and Current Good Manufacturing Practices (cGMP) guidelines.

Key Responsibilities / Accountabilities:

  • Provide process support and troubleshooting necessary to meet all customer requirements.
  • Maintain the facility in excellent FDA/cGMP posture. Ensure a level of housekeeping appropriate for a pharmaceutical manufacturer and maintain 5S areas.
  • Responsible for safety equipment and active participation in safety program and hazard analysis. Wear appropriate PPE for task.
  • Ensure that waste is appropriately characterized, labelled, stored and disposed in compliance with all Company, state and federal regulations. Work 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. Work collaboratively with Maintenance, as appropriate.
  • Ensure the security and safe handling of all controlled substances at all times. Strictly adhere to all Company and DEA regulations.
  • Active member of Emergency Response Team. Participate in Emergency Response Training and related activities.

Qualifications:

  • High School Diploma with 3-5 years' experience in an API manufacturing facility.
  • Good understanding of GMPs and FDA regulations required.
  • Experience with glass lined reactors, nutsche filters, purified water systems and vacuum pumps.
  • Ability to drive a forklift preferred.

Additional Information:

All your information will be kept confidential according to EEO guidelines. Veranova is an Equal Opportunity Employer.



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