Quality Control Technician (Wilcrest Pharma)

Job Description

Job Description

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.