Biologics Manufacturing Operations Specialist

1 month ago


Copenhagen, Copenhagen, Denmark AGC Inc Full time

Job Summary

We are seeking a Biologics Manufacturing Operations Specialist to support our operations by reviewing inputs, documentation and records required for manufacturing of biologic products.

This role is responsible for providing QA support under guided direction to operations and compliance with cGMP, FDA, and ICH. The ideal candidate will have a strong understanding of procedures and methods for review function, as well as the ability to interact with cross-functional teams to ensure the compliance of the GMP operations at the site.

Responsibilities

  • Review executed Master Production Records (MPRs) and other support documentation for completeness, compliance, and accuracy to support product lot disposition.
  • Provide general support for manufacturing operations in the resolution of issues, non-conformities, and deviations.
  • Collaborate with stakeholders to resolve GMP errors and approve results summaries.
  • Support issuance activities for Master Production Records and other records, as needed.
  • Review and approve preventative maintenance and repair work orders related to equipment or facilities.

Requirements

  • A minimum of 0-2 years of relevant experience in biologics manufacturing.
  • Bachelor's degree in Biology, Chemistry or other relevant discipline.
  • Strong analytical and problem-solving skills, with the ability to work independently and collaboratively as part of a team.
  • Excellent communication and interpersonal skills, with the ability to effectively communicate with cross-functional teams.

Benefits

The successful candidate will receive a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer and welcomes applications from all qualified candidates.

Estimated Salary: $28.50 - $38.20 per hour



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