Overview
QC Laboratory Technician Jobs in Billerica, MA at Sun Pharmaceutical Industries, Inc (USA)
What We Are Looking For
As a Quality Control Technician, you will support the production of safe, high-quality sterile and nonsterile medications by overseeing QC testing activities, coordinating sample management, and assisting with environmental monitoring programs. Your attention to detail, adherence to CGMP, and technical skills will help ensure our products meet strict quality standard and regulatory requirements.
What You Will Do
Collect and prepare samples for third-party testing, ensuring proper chain of custody and documentation.
Support environmental monitoring (EM) activities including viable air, surface, and personnel monitoring within classified areas.
Maintain QC sample inventory, including retention samples, stability samples, and in-process controls, ensuring proper storage and documentation.
Document and investigate out-of-specification (OOS) results, environmental monitoring excursions, and assist with root cause analysis and CAPA implementation.
Perform visual inspections of finished products for appearance, particulates, and container-closure integrity per approved specifications.
Review laboratory and third-party testing data for accuracy, completeness, and compliance with specifications.
Coordinate with third-party laboratories to schedule stability and routine testing and ensure timely reporting and documentation of results.
Support for the preparation of regulatory inspections, customer audits, and internal audits by maintaining accurate and current QC documentation.
Maintain and upload QC records into the electronic document management system to ensure traceability and CGMP compliance.
Support the Quality and Production teams, and work cross-functionally with other teams as needed, along with additional duties as assigned by the Director of Quality.
Who You Are
Education: Associate’s degree preferred, or equivalent experience in a CGMP-regulated environment.
Experience: 1+ years of experience in Quality Control in a CGMP regulated environment, preferably within a pharmaceutical manufacturing, cell or gene therapy manufacturing, or analytical laboratory setting.
Skills:
o Strong understanding of CGMP regulations, pharmaceutical quality control practices, and environmental monitoring principles.
o Skilled in laboratory sample handling, documentation practices, and review of analytical test reports.
o Analytical, detail-oriented, and proactive with modern problem-solving skills to identify and address quality issues.
o Proficient in Microsoft Office (Word, Excel, Outlook); familiarity with electronic documentation systems and laboratory information management systems (LIMS) is a plus.
Who We Are
Wilcrest Pharma is 503B outsourcing facility dedicated to addressing critical gaps in the pharmaceutical industry. Our mission is to deliver high-quality antineoplastic medications and help mitigate drug shortages, enhancing patient care across health systems, clinics, pharmacies, and other healthcare providers.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
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Title: QC Laboratory Technician
Company: Sun Pharmaceutical Industries, Inc (USA)
Location: Billerica, MA
