Quality Assurance Director
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
If you are interested in the job opportunity below, please forward resume, cover letter, and salary history to email@example.com.
About the Opportunity
We are looking for a talented individual to fill a Quality Assurance Director position at our Ann Arbor, MI facility. The QA Director is responsible for developing, coordinating, and supervising the implementation and maintenance of a GMP compliant Quality Management System throughout the laboratory. This position reports to the CEO of Avomeen.
Position Summary Responsibilities
- Acts as leader of the Quality Assurance (QA) unit. Responsible for developing, coordinating, implementing and monitoring a quality management system throughout the facility which is compliant with regulatory requirements set forth by the DEA, FDA, ISO 17025, and OSHA.
- Performs internal and periodic audits of the laboratory, manufacturing operations, work processes, study reports and quality records to ensure compliance with regulatory requirements, standard operating procedures, and polices.
- Manages the controlled substance (CS) program and ensures compliance with DEA requirements. Assists in procuring, storing, inventorying, and disposal of CS.
- Manages accreditation applications and renewals including DEA licensing, FDA registration, and ISO 17025. In addition, coordinates and responds to regulatory, client, and third-party quality assessments.
- Manages the document control system including development, review, and revision of SOPs and policies, document archival, and record retention.
- Trends, monitors, and improves the major areas of the quality system such as CAPA, change control, customer feedback and complaints, investigations, deviations, and on-time delivery.
- Develops and implements on-going employee training programs related to the quality management system.
- Manages metrology and preventative-maintenance program to ensure instruments and equipment are in good working order, properly qualified and calibrated per their pre-determined frequencies.
- Executes any other special projects as assigned by the executive management team.
- Advanced degree in a scientific discipline
- 6+ years’ experience in a quality role in a cGMP environment as a manager or director
- 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