Job Title: Quality Control (QC) Compliance SpecialistJob DescriptionThe QC Compliance Specialist, under the direct supervision of QC Management, is responsible for leading compliance-related activities and tasks for the QC laboratory. This includes conducting laboratory investigations, authoring technical protocols and reports, performing data reviews and trend analyses, providing timely escalation of compliance-related issues, and assisting management with other compliance-related tasks as assigned.
Responsibilities- Perform routine and process environmental monitoring in an aseptic manufacturing environment.
- Conduct sampling and testing of clean utilities (compressed air, Nitrogen, WFI/DIW, and Clean Steam).
- Perform Bioburden, Endotoxin, Total Plate Count, Coliform, Bacteriostatic & Fungi stasis (B&F), Biological Indicator testing, and Plate Reading.
- Write/review material specifications and perform material qualifications (media and reagents).
- Initiate and investigate microbiology-related deviations (NCEs), OOS investigations, and implement appropriate CAPAs as needed.
- Operate Sterility Isolator and perform routine maintenance and testing as needed.
- Perform routine QC responsibilities such as sample coordination, peer review, lab equipment maintenance, QC document management, QC inventory control, and reconciliation of sample requests/documents.
- Monitor laboratory equipment for temperature, humidity, etc., and ensure conformance to specifications.
- Specialize in method development of microbiological methods in one or more disciplines of Microbiology.
- Develop methods for new products/components, author protocols and test methods, execute and troubleshoot findings.
- Act as a subject matter expert in one or more fields of microbiology (e.g., BET, Bioburden Testing, AET, Microbial Identification, Sterility Testing, LIMS).
- Work weekends, overtime, on-call, and holidays as needed.
- Serve as Lead investigator and writer for lab-related issues, conduct formal investigations, and ensure lab investigations are completed within required time schedules.
- Ensure root cause, corrective action, preventative action, and product impact are thoroughly addressed in investigations.
- Develop, implement, manage, and track the effectiveness of corrective action plans for exceptions.
- Participate in Quality Review Board representing the QC Laboratory and communicate status, root cause, and CAPAs.
- Coordinate and lead USP/EP/ICH Committee to assess and trigger change implementation to remain in compliance.
- Assist in the review, approval, and issuance of laboratory documents including SOPs, testing protocols, and new testing methodologies.
- Assist with GMP Compliance program in the QC Laboratory, including management of training records, internal and self-audits, compliance walkthroughs, SOPs and Methods, and deviation reduction initiatives.
Essential Skills- Bachelor's Degree in a scientific/technical discipline.
- Minimum of 3 years of industry experience with at least one year in QC Laboratory settings.
- Expertise in performing laboratory investigations, change controls, and associated CAPAs under limited guidance.
- Working knowledge in Labware LIMS configuration of new analyses and product specifications.
- Working knowledge of analytical method development, transfer, and validation methodologies and relevant guidance.
- Knowledge of USP/EP/cGMP and ICH guidelines.
- Familiarity with Laboratory Information Management System (LIMS), Global Quality Tracking System (TrackWise), Microsoft Office, Lean Six Sigma concepts, Lean Labs, project management, formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.
Additional Skills & Qualifications- Experience in microbiology, biology, environmental monitoring, and laboratory plating.
- Expertise in data review and trend analysis.
- Ability to train new hires and act as an SME in one or more disciplines in the area of Microbiology.
- Strong communication skills to effectively report findings to Site Leadership and act with a sense of urgency.
Work EnvironmentThe role requires the ability to stand on feet for up to four hours at a time, lift, push, and/or pull up to 25 pounds, and independently gown for aseptic processing. The candidate must meet minimal visual acuity requirements necessary for quality assessments in a production or packaging environment. The job involves moving freely around a manufacturing environment, including moving about on stairs, ladders, and around machines with moving parts. Frequent standing, bending, stooping, and prolonged working overhead is required. Occasionally, the role involves ascending/descending a mezzanine staircase to take samples. Flexibility in the work schedule, including weekends, holidays, and overtime, is required.
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email ...@actalentservices.com for other accommodation options.