Stability Quality Control Technologist III- Transfusion

Overview

Immucor has an exciting opportunity for a QC expert. We are looking to hire a Quality Control Technologist III in the medical device and/or pharmaceutical industry. This critical role will lead QC stability projects, perform incoming, in-process, final release, and stability testing in the Quality Control Laboratory. The individual will act as Team Lead in the QC lab to assist supervisor and Director in daily operations of the Quality Control Laboratory and provide guidance to the QC staff.

Job Summary

This role will be the team SME (subject matter expert) on product stability. This will include writing stability protocols and reports, performing product testing, and trending stability data.

They may lead QC projects, perform incoming, in-process, final release, and stability testing in the Quality Control Laboratory. They will be a Team Lead in the QC lab to assist the supervisor/ manager and Director in daily operations of the Quality Control Laboratory and provide guidance to the QC staff.

Key Accountabilities

• Monitors stability testing time points, ensures samples are pulled and tested at the correct intervals, and performs data analysis to support QA/QC management. Drafts stability protocols and reports. Performs trend analysis on stability data throughout the stability protocol timeline. Develops timeline for annual stability and determines which products are required.
• Provides direction and guidance to Quality Control staff in the performance of daily tasks. Creates daily and weekly scheduling of all QC related activities.
• Performs and schedules testing for incoming raw material, in-process, final release and inspection of Bio Array products according to approved Standard Operating Procedures (SOP’s) and other applicable documents within defined time frames. Performs and schedules stability, method validations, equipment validations, threshold analysis process and other special testing.
• Act as OJT trainer to train new employees and current employees on new test methods. Guides QC technicians training activities and ensures that the appropriate training records are completed as per the role functions.
• Reports and escalates out-of-specification results and deviations to the department supervisor/manager. Assists and leads the investigations, root cause analyses, and reports for out-of-specification results and deviations.
• Writes/Revises SOPs, WI, QC Specification/testing documents. Maintains accurate, legible, and complete records according to Current Good Manufacturing Procedures (cGMP’s).
• Performs all assigned tasks following applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Blood borne pathogens and chemical hazards).
• Maintains work area, equipment, department, and all storage areas in a clean, neat, and orderly manner. Performs, schedules and delegates equipment calibration and maintenance.

• Bachelor’s degree in biology or chemistry or related field. Four (4) or more years experience in a medical device or pharmaceutical GMP quality laboratory. Experience working under 21 CFR Part 210/211 and/or 820 regulations required. Knowledge of ISO 13485 desired.
• Two (2) or more years of experience performing stability testing required. Experience writing stability protocols, performing data trending, and writing stability reports preferred.
• Experience performing OOS Phase I investigations, in alignment with FDA guidelines, required.
• Expereince training QC technicians desired.
• Expereience performing PCR (Polymerase chain reaction) desired.
• Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact N for assistance.