Environmental Monitoring Specialist

25 days ago

Holly Springs, North Carolina, United States

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Job Description

Aequor is seeking an Environmental Monitoring Specialist in Holly Springs, NC, for a 12+ month onsite contract role. The candidate should have experience in the pharmaceutical industry, focusing on environmental monitoring and performance qualification. Responsibilities include developing protocols, overseeing EM sampling, data collection, and technical report writing. Strong project management skills and knowledge of GMP regulations are essential. A bachelor's degree is preferred, but relevant experience is prioritized.
Job Title: Specialist Quality Control

Location: Holly Spring NC (100% Onsite)

Duration: 12+ Months with Possible extension

Terms: Contract W2

100% onsite for holly Springs.

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

Aequor Allied


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Website:aequor.com

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