Off-Site Project Manager EMPQ – Framingham
The function of the Off-Site Project Manager is to oversee the environmental monitoring performance qualification (EMPQ) at a client site. Responsibilities include protocol and report authoring, and performance of an EM risk assessment in accordance with HACCP and other client requirements. Other duties may be assigned as needed. This position is located in Framingham, MA.
PRIMARY DUTIES AND RESPONISIBITIES
- Author In Situ and EM PQ protocols for a new controlled area, including the sampling plan and determining specifications, to meet client and cGMP requirements.
- Oversee the risk assessment of the controlled area, and author the risk assessment document, to meet client, HACCP, and cGMP requirements.
- Author final reports for the EM PQ, and provide data compilation for the client as needed.
- Oversee execution of the EM PQ, in coordination of with BA laboratory management and client contacts. Coordination will include overseeing BA and client personnel performing sampling, ensuring documentation is performed appropriately, and ensure results are reported as required.
- Ensures all work performed is performed in compliance with Standard Operating Procedures, Good Manufacturing Practices, Regulations of the Food and Drug Administration, Company, Client and Pharmacopeial Methodologies.
- Follows all safety rules and regulations.
- Follows all cGMP rules and regulations.
- Documents work in a clear and organized manner.
REQUIREMENTS & QUALIFICATIONS
- BA or BS degree in Microbiology or related science discipline.
- 5 to 7 years of related experience is required.
- Knowledge of cGMP and related compliance regulations and guidances is required.
- Must be HACCP (Hazard Analysis Critical Control Point) certified.
- There are portions of this position that may be done remotely, but travel to Framingham to oversee project progression is required.
- The ability and skill to perform the detailed job requirements noted above competently, safely, and proficiently.
- A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.
- Must have excellent organizational, verbal communication, and technical documentation skills.
- Must have excellent technical writing skills.
- Solid computer skills.
- Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.
- Must be a team player with integrity and concern for the quality of Company products, services and staff members.