Our client, a Global Leader in the Medical Device Industry, has an immediate opening for a Laboratory Data Quality Specialist for a 12-month+ contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment. 

The Data Reviewer - Quality Control Laboratories (Microbiology & Chemistry) is responsible for the thorough and independent review of microbiological and chemistry laboratory data to ensure accuracy, data integrity, and compliance with applicable regulatory and quality system requirements. This role supports the Quality organization by verifying test results, performing initial laboratory investigations, and ensuring timely, complete, and compliant documentation to support product disposition and release. The position requires strong attention to detail, sound scientific judgment, and close collaboration with laboratory and quality partners to ensure the delivery of high-quality, compliant products.

Responsibilities

• Performing detailed reviews of microbiological data, including routine and non-routine analyses of raw materials, in-process solutions, and finished products.
• Reviewing antimicrobial effectiveness testing, microbial growth promotion, environmental monitoring, cleaning surveillance, media qualification, and microbial identification.
• Conducting reagent reviews to ensure compliance with regulatory standards.
• Conducting Phase I laboratory investigations to support quality assurance efforts.
• Ensuring data integrity and documentation accuracy in accordance with cGMP and regulatory guidelines.
• Collaborating with laboratory personnel to address data discrepancies and resolve compliance concerns.
• Utilizing Microsoft Office applications to document findings and generate reports.
• Performing other duties as needed to support quality and compliance initiatives.

Requirements 

• Bachelor's degree in a relevant field.
• 1-2 years of experience working in a GxP laboratory environment.
• Proficiency in Microsoft Office applications.
• Strong written and oral communication skills in English.
• Experience working in current Good Manufacturing Practice (cGMP) or other cGxP environments.
• Experience performing microbiology data reviews.
• Experience using a Laboratory Information Management System (LIMS).
• Experience with technical writing in a regulated environment