Quality Assurance Specialist

Company: Planet Pharma
Location: Grand Rapids
Posted on: February 23, 2021

Job Description:

In search of QA consultants but not senior level. They will be on the floor working. The role that they will hire fulltime is just a QA Specialist II. So it is OK for our consultants to be more senior than what this job spec requires.

• Support quality systems as they relate to the manufacturing and testing of cGMP drug products.
• These duties will include but are not limited to: providing oversight and general support for the manufacturing of aseptic processes, deviation and CAPA systems, batch record review, SOP creation and revision, review of quality documents, and supporting the Quality Management System.
  Responsibilities:
  • Provide on the floor Quality oversight within the warehouse and manufacturing areas to support compliance with procedures and manufacturing documentation during operations with minimal guidance
  • Establish and maintain good technique with regards to working in classified areas (including gowning qualification)
  • Review and approve executed batch records and other associated controlled documents
  • Perform QA review in-process and environmental monitoring test results
  • Perform QA review and material release for incoming materials
  • Perform triage and impact assessment for deviations associated with the aseptic filling process.
  • Participate in cross functional teams to support quality investigations
  • Perform tasks within the quality systems with an understanding of the correlation between systems, such as the relationship between a deviation and CAPA.
  • Perform routine tasks within the quality systems, such as Work Orders, Calibration Forms, etc.
  • Identify and participate as a team member in continuous improvement efforts
  • Perform job responsibilities in compliance with cGMPs, company standards operating procedures, and industry best practices --- Open to a flexible and fluid work environment
  • Support Agency, customer and vendor audits as needed.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices
  • Perform all other tasks, projects, and duties as assigned
  • Perform training of Specialist I's, as necessary
    Requirements: --- Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment This level of knowledge is normally acquired through completion of a Bachelor's Degree in Life Sciences or related field, and 2-5 years related work experience. In lieu of a Bachelor's Degree, equivalent GMP/related work experience may be considered.

Keywords: Planet Pharma, Grand Rapids , Quality Assurance Specialist, Other , Grand Rapids, Michigan