What are the responsibilities and job description for the Specialist Quality Control (Environmental monitoring) position at Infotree Global Solutions?
Description:
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 Client 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
Basic Qualifications
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience
Top 3 Must Have Skill Sets:
- Environmental Monitoring experience (especially EM PQ protocols and project involvement).
- Ability to own and manage projects/protocols with minimal guidance.
- Strong organizational skills, managing and trending large sets of data.
Day to Day Responsibilities:
- Assist with drafting and reviewing EM Performance qualification protocols and reports.
- Help manage EM Performance qualification execution, including tracking sample status, reviewing results, coordinating sampling, and compiling data for final reports.
- Assist with implementation of trending program for EM and Utilities monitoring and perform trending of routine monitoring following completion of PQ activities.
- Oversee identification program for microbial recoveries during EM and utilities sampling and trend identifications for final reports.
- Assist with excursion investigations during EM performance qualification and routine monitoring.
