QC Compliance Specialist- Microbiology Job Listing at Kelly Services in Morris Plains, NJ (Job ID US3530487_BH9713947)

Description

Job Title: QC Compliance Specialist (Intermediate Microbiologist)
Job Summary: The QC Compliance Specialist, under the direct supervision of QC Management, is responsible for leading compliance-related activities within the QC laboratory. This role requires an intermediate-level microbiologist with expertise in method validation protocol writing, Bioburden and Endotoxin testing, and microbiology investigations. The QC Compliance Specialist will lead laboratory investigations (including OOS/OOT), author technical protocols and reports, perform data reviews, conduct trend analysis, and support compliance initiatives. The Specialist will serve as the lead investigator and writer for lab-related issues, ensuring all compliance tasks and investigations are completed efficiently and thoroughly.
Key Responsibilities:

• Lead and conduct laboratory investigations, including Out of Specification (OOS) and Out of Trend (OOT) events, ensuring alignment with quality systems and regulatory procedures.
• Act as the primary investigator and writer for lab-related issues, ensuring investigation documentation addresses root cause, corrective actions, preventive actions (CAPA), and product impact.
• Immediately communicate OOS findings to site leadership and act with urgency to initiate investigations.
• Ensure all laboratory investigations are completed within required timelines as per quality systems and procedures.
• Develop, implement, and monitor corrective action plans for laboratory exceptions, ensuring proper documentation and resolution.
• Represent the QC laboratory in Quality Review Board meetings, providing updates on investigations, root cause analysis, and CAPA status.
• Lead the USP/EP/ICH Committee, assessing and ensuring compliance with industry standards.
• Assist in the review, approval, and issuance of laboratory documents such as SOPs, testing protocols, and new testing methodologies.
• Support GMP compliance efforts within the QC laboratory, including managing training records, conducting internal audits, performing compliance walk-throughs, and contributing to deviation reduction initiatives.
• Stay current with regulatory guidelines (USP/EP/cGMP, ICH) and ensure laboratory practices are fully compliant.
• Manage microbiological testing and investigations related to Bioburden and Endotoxin testing.

Required Education, Qualifications, and Skills:

• Bachelor's degree in a scientific or technical discipline, preferably Microbiology.
• Minimum of 3 years of industry experience, with at least 1 year in a QC laboratory setting.
• Expertise in performing laboratory investigations, change controls, and CAPA, under limited supervision.
• Experience with Bioburden and Endotoxin testing, as well as microbiology investigations.
• Strong knowledge of Labware LIMS configuration for new analyses and product specifications.
• Experience with analytical method development, transfer, and validation methodologies.
• Familiarity with USP/EP/cGMP, ICH guidelines, and Laboratory Information Management System (LIMS).
• Proficiency with Microsoft Office, TrackWise, and other relevant systems.
• Understanding of Lean Six Sigma concepts, Lean Labs, project management, and formal quality control systems.
• Experience in quality risk management, including risk assessments.

Preferred Skills:

• Lean Six Sigma certification.
• Previous experience leading compliance and quality improvement initiatives.
• Excellent verbal and written communication skills with a strong attention to detail.
• Strong organizational skills and the ability to manage multiple priorities effectively.

 

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

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Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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