Quality Control Technician

Position Overview

The purpose of this position is to provide support services by means of executing the analysis of in-process, finished product, and stability test samples. Further support services include Environmental Monitoring and Raw Material receipt activities. QC personnel are responsible for compliance with QC policies and procedures within the QC laboratory, company policies, and cGMP guidelines. This position will report to the Director, Quality Control.

This role is 100% On-Site, Monday - Friday 8 hours/day (excluding lunch break). Overtime, weekends and holidays may be required. Flexible start time between 6:00am and 9:30am with a consistent schedule. Exceptions to the schedule must be approved by the manager in advance.

Responsibilities and Duties

• Execute incoming inspection of raw materials in accordance with company policy and procedures
• Conduct environmental monitoring for the facility on a routine basis per applicable SOPs including sampling of the USP Purified Water system and associated plant utilities
• Assist in the expedition of test sample shipment to sponsors and 3rd party laboratories
• Execute deviation/OOS investigations and implement CAPAs and change controls per GMP requirements, as needed
• Assist in the execution of analytical method transfer activities, including product-specific test methods
• Directly contributes to daily laboratory operations for QC Chemistry and Microbiology, in full compliance with applicable SOPs and safety guidelines
• Analyzes on a routine basis in-process, release, and stability test samples in accordance with established QC test methods and specifications
• Assumes the role of safety liaison with EHS and Safety Officer
• Assists QA in calibration/preventive maintenance activities associated with lab instrumentation

Education and Experience

• Undergraduate degree (B.A. or B.S.) in a Life Science discipline
• 3-4 years' GMP experience in a Quality Control function within the medical device and/or biopharmaceutical fields
• Direct experience with EM sampling and aseptic technique
• The ability to perform daily tasks with a keen attention to detail
• An affinity for precise and detailed documentation skills
• The ability to work effectively and contribute to a dynamic and fast-paced work environment
• Well-developed oral communication and listening skills
• Applicable academic or industrial laboratory experience
• High-level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction