What are the responsibilities and job description for the Environmental Monitoring Specialist position at SSi People?
Ideal Candidate:
- The ideal candidate for this Specialist Quality Control role will have direct experience working in the pharmaceutical or biopharmaceutical industry, specifically supporting environmental monitoring (EM) programs and performance qualification (PQ) activities. They should be comfortable working in a fast-paced startup environment and capable of assisting with protocol development, executing and overseeing EM sampling, organizing large volumes of data, and contributing to technical report writing. Strong project management and organizational skills are essential, as is a working knowledge of GMP regulations and industry standards. A bachelor's degree is preferred, but demonstrated hands-on experience in EM PQ is the top priority.
Position Summary:
- The Specialist Quality Control will report directly to the Senior Manager, QC Microbiology, providing support for startup of the Environmental Monitoring and Utilities Monitoring programs at North Carolina. Working directly with the EM and Utilities Monitoring Program Owner, this role will provide SME oversight for EM Performance Qualifications, EM Risk assessments to determine sampling strategy, identification of microbial recoveries, and implementation of trending program.
- This is a highly technical, project-driven role supporting a critical startup phase at the ANC site. The Specialist will play a key role in executing protocols, collecting and analyzing data, and supporting the implementation of a routine environmental monitoring program following the completion of performance qualification efforts.
Key Responsibilities:
- Support the development and execution of EM PQ protocols and sampling plans
- Provide oversight for EM sampling execution and data collection
- Assist in drafting technical reports and supporting documentation
- Collaborate with internal teams to establish routine EM programs and sampling schedules
- Lead efforts to implement trending procedures on a monthly, quarterly, and annual basis
- Manage microbial isolate identification processes and related documentation
- Contribute to data organization and trending analysis for continued program improvements
