Quality Assurance Specialist

Avomeen Analytical Services is a fast-paced, growing company. We are searching for a talented and motivated individual to fill a position of Quality Assurance Specialist in a team oriented, entrepreneurial environment in Ann Arbor, Michigan.

As the QA Specialist you will be responsible for developing, coordinating, and supervising the implementation of a GMP compliant Quality Management System throughout the laboratory. You will need to collaborate with laboratory management to ensure that the Quality System is applied effectively. This position reports to the CEO of Avomeen.

Position Summary Responsibilities:

  • Develop, coordinate implementation, and monitor a GMP quality system throughout the facility
  • Manage laboratory accreditation applications and renewals including DEA licensing and ISO registration
  • Coordinate, perform, and review internal audits of the laboratory quality program
  • Coordinate development, review, and revisions of Standard Operating Procedures
  • Audit laboratory compliance to Standard Operating Procedures
  • Monitor compliance to completion of laboratory investigations and corrective and preventative actions
  • Coordinate and respond to regulatory, client, and third party quality assessments
  • Coordinate document and record control
  • Coordinate IQ/OQ and periodic certification and/or calibration of laboratory equipment
  • Develop and implement on-going employee training programs related to the Quality Management System
  • Audit and approve project work for compliance to company SOPs as well as GMP requirements
  • Other duties and responsibilities may be required as needed

Desired Qualifications:

  • B.S. in a scientific discipline, preferably chemistry
  • 3+ years’ experience in a quality role in a cGMP environment as an auditor, coordinator, or manager
  • Experience in a contract analytical laboratory setting
  • Experience with authoring GMP compliant Standard Operating Procedures
  • Experience with FDA and client facility audits
  • A highly motivated self-starter that can work with minimal supervision

Location:

Ann Arbor, Michigan

Compensation:

Negotiable

To apply, send the following requested information to hr@avomeen.com:

  • Resume
  • Salary requirements