Quality Control Technologist III-Stability - Transfusion and Transplant

Werfen•Warren, NJ

About The Position

Introduction Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care. Overview If you’re a QC expert when it comes to manufacturing, Immucor has an exciting opportunity for you! We are looking to hire a Quality Control Technologist III medical device, and/or the pharmaceutical industry. This critical role will Lead QC stability projects, perform Incoming, In-process, final release and stability testing in the Quality Control Laboratory. 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. This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time . Responsibilities 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/ manger and Director in daily operations of the Quality Control Laboratory and provide guidance to the QC staff.

Requirements

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.
Two (2) or more years of experience performing stability testing required.
Eperience performing OOS Phase I investigations, in alignment with FDA guidelines, required.

Nice To Haves

Knowledge of ISO 13485 desired.
Experience writing stability protocols, performing data trending, and writing stability reports preferred.
Expereince training QC technicians desired.
Expereince performing PCR (Polymerase chain reaction) desired.

Responsibilities

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 onstability data throughout the stabiity 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 BioArray products according to approved Standard Operating Procedures (SOP’s) and other applicable documents within defined timeframes.
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 manintenance.