Quality Assurance Specialist
Analytical Chemistry Laboratory – Avomeen Analytical Services – Ann Arbor, MI
Are you looking for a fast paced position in a rapidly growing Analytical Chemistry Laboratory? We are currently seeking to fill a variety of positions at our Ann Arbor, Michigan facility. We are searching for talented and motivated individuals that would enjoy working in a team oriented, entrepreneurial company.
Avomeen is part of the CRO industry, which serves Pharmaceutical, Biotech, Legal, Automotive, Paints & Coatings, and other diversified industries with laboratory services. This $600B dynamic industry has risen to fill the needs of a wide variety of companies that have realized that Analytical Science is not core to their mission and is better done in an outside science based organization that values and supports it.
At Avomeen we:
- Perform analysis to get approvals for innovative as well as generic pharmaceuticals
- Perform testing as well as Expert Witnessing for Law firms to support litigation
- Re-engineer and improve existing products for new markets and applications
- Invent new products (several clients have appeared on Shark Tank)
- Solve major quality problems for manufacturers including soft drink companies, auto manufacturers, pharmaceutical manufacturers, and others
About the Opportunity
We are looking for a talented individual to fill a Quality Assurance Specialist position at our Ann Arbor, MI facility.
In this position, 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
- 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
To apply, email your resume, cover letter, and salary history to firstname.lastname@example.org
Avomeen Analytical Services is an Equal Opportunity Employer.