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Senior Associate in Manufacturing Operations

2 months ago

Farmington, Iowa, United States Quality Consulting Group Full time
Job Overview

Quality Consulting Group, a prominent entity in the pharmaceutical, biotechnology, medical devices, and manufacturing sectors, is seeking a skilled and driven individual to fill the role of MCS Manufacturing Sr. Associate. This position involves collaborating with a dynamic team dedicated to excellence in the manufacturing domain across various locations.

Key Responsibilities:

  • Manage New Product Introductions (NPI) and oversee non-capital project initiatives.
  • Ensure comprehensive and compliant change control documentation in accordance with GMP regulatory standards.
  • Facilitate the timely resolution of change control records following procedural guidelines and timelines.
  • Act as the representative for the manufacturing facility regarding incoming Technology Transfers and New Product Introductions.
  • Identify and advocate for improvement opportunities within the organization, fostering consensus for implementation.
  • Present documentation and business processes to diverse audiences, including regulatory auditors and inspectors.
  • Lead and participate in Continuous Improvement Transformation initiatives.
  • Promote safety and compliance as a fundamental priority.
  • Oversee Change Controls for the introduction of new products in both Clinical and Commercial Drug Product manufacturing.
  • Engage in drug product manufacturing operations.

Qualifications:

  • Master's Degree in life sciences or engineering.
  • A minimum of 2 years of relevant experience.
  • Experience in Project Management.
  • Familiarity with PAS X Werum software for electronic batch records.
  • Technical knowledge of Drug Product (DP) manufacturing processes, including buffer batching, DP formulation, DP filling, and inspection.
  • Experience leading change controls using Trackwise.
  • Strong scientific and technical collaboration with partner organizations such as Process Development, Process Engineering, Supply Chain, Quality Control, and Regulatory Affairs.
  • Experience working within cross-functional teams.
  • Knowledge of deviations and change management processes.
  • Proficient technical writing skills.
  • Ability to work administrative shifts.

Quality Consulting Group, LLC is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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