Sr Analyst, Compliance Specialist - QC Microbiology

RoslinCT US•Hopkinton, MA

4d•$77,000 - $115,000

About The Position

A Senior Analyst or Compliance Specialist in Quality Control (QC) Microbiology oversees microbial testing, environmental monitoring, and regulatory compliance in pharmaceutical and biotech manufacturing. They ensure testing data integrity, manage deviations, and act as subject matter experts during audits.

Requirements

Excellent/Effective written and verbal communications skills.
Prepare technical data and present to senior leadership.
Escalate issues professionally and on a timely basis.
Ability to adhere to timelines for testing and reporting of data
Ability to function in a team-oriented environment
A highly organized work style that ensures timely execution of tasks.
A mindset that ensures accurate results.
Effective problem-solving capabilities.
Bachelor’s degree in biology (Microbiology), Biology, or a related life science.
4 to 6+ years of GMP laboratory experience within a sterile or biotech environment.
Experience with data review in a cGMP QC laboratory environment performing environmental monitoring, rapid microbiological methods (rapid sterility, endotoxin).
Strong working knowledge of USP, cGMP, FDA, and data integrity guidelines.

Responsibilities

Ensure data is accurate and up to date. This includes timely review of documents and coordination with other organizations to meet timelines.
Perform or review endotoxin, sterility, growth promotion and routine testing alongside cleanroom environmental monitoring.
Identification and implementation of process improvements.
Development of processes that will support staff and department evaluation and growth
Ensure that work is completed in accordance with requirements including but not limited to CFR's, cGMPs, SOPs, and company policies.
Ensure cGMP compliance and maintain quality standards for all manufacturing activities.
Initiate plans and processes which minimize costs through effective utilization of manpower
Support implementation of information technologies that support documentation and data management systems.
Participate and lead in investigations, change controls and CAPAs.