Quality Control Technician

What We Are Looking For

As a Quality Control Technician, you will play an important role in helping Wilcrest Pharma deliver safe, high-quality sterile and non-sterile medications. In this role, you will support QC testing activities, sample management, environmental monitoring, finished product inspection, labeling, and packaging support.

What You Will Do

• Collect, prepare, and coordinate samples for third-party testing, ensuring proper chain of custody documentation, storage and timely submission.

• Conduct environmental monitoring (EM) activities including viable air, surface, and personnel monitoring within manufacturing areas.

• Execute assigned qualification and validation activities, including environmental monitoring studies, equipment qualification activities, and sample collection.

• Maintain QC sample inventory, including retention samples, stability samples, and in-process controls, ensuring proper storage and documentation.

• Perform assigned finished product inspection and packaging support activities, including visual inspection, product labeling, label verification/reconciliation, heat sealing, and completion of required documentation.

• Review laboratory and third-party testing data for accuracy, completeness, and compliance with approved specifications.

• Support quality investigations related to out-of-specification (OOS) results, environmental monitoring excursions, inspection discrepancies, labeling issues, and packaging concerns.

• Coordinate with third-party laboratories to schedule routine, release, and stability testing and support timely reporting and documentation of results.

• Support preparation for regulatory inspections, customer audits, and internal audits by helping maintain accurate, complete, and inspection-ready QC documentation.

• Maintain and upload QC records into the electronic documentation management system to support traceability and CGMP compliance.

• Collaborate with Production and other cross-functional teams as needed, and perform 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 Quality Control experience in a CGMP regulated environment, preferably within a pharmaceutical manufacturing setting.

• Skills:

o Understanding of CGMP requirements, pharmaceutical quality control practices, and environmental monitoring principles.

o Experience in sample handling, documentation practices, and review of analytical test reports.

o Comfortable performing sterile and nonsterile gowning activities and working within classified manufacturing environments in accordance with established gowning, contamination control, and aseptic practices.

o Ability to stand for extended periods and lift up to 20 pounds, as needed to perform sampling, monitoring, inspection, and packaging support activities.

o Detail-oriented, organized, and proactive, with the ability to identify quality issues and support effective problem solving.

o Comfortable working both independently and collaboratively in a fast-paced, regulated environment.

o Must meet visual acuity and color vision requirements necessary to perform finished product visual inspection in accordance with USP <790> and internal qualification procedures.

o Proficient in Microsoft Office, including Word, Excel, and Outlook; familiarity with electronic documentation systems or 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 (https://www.eeoc.gov/poster) notice from the Department of Labor.