QA Manager - Full-time / Part-time

Our client, located in Coral Springs, is seeking a QA Manager for a 6 month contract.

Responsibilities:

• Develop, establish and roll-out quality systems and controls in support of CTM manufacture and release.
• Lead commissioning and qualification of facilities, instruments, equipment and software.
• Independently draft and establish SOPs, work flows, work instructions working in collaboration with technical and non-technical stakeholders.
• Provide QA oversight to R&D (Product Development, QC and Operations) groups, including clinical trial material manufacture and QC release of products to clinic.
• Provide leadership, direction, and approval of cGMP documentation, including but not limited to: electronic quality modules; environmental monitoring; utilities; materials control and flow (receipt, storage, shipment); equipment and instrument qualification, validation and maintenance programs; IT systems (e.g., laboratory information management system (LIMS); stability program, deviation/investigations, training records etc.
• Train relevant stakeholders on quality systems by developing training programs and disseminating trainings.
• Perform internal inspections and audits. Respond to all customer & regulatory agency inspection findings.

Require Experience:

• Bachelor's Degree or Master's Degree
• 10 years of experience in an FD-Regulated or pharmaceutical environment.
• 6 years of experience in quality-management.
• Knowledge of cGMP and ISO regulations
• Experience in laboratory practices, release of materials and products and conducting investigations.

About Aerotek: Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit aerotek.com. Aerotek is acting as an Employment Agency in relation to this vacancy.