Stability Quality Control Technologist III-- Transfusion at Werfen GmbH

Warren Township, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Jun, 26

Salary

0.0

Posted On

08 Mar, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Stability Testing, Quality Control, SME, Data Analysis, Protocol Writing, Report Writing, Trend Analysis, Incoming Testing, In-Process Testing, Final Release Testing, OJT Training, SOP Writing, cGMP, OOS Investigations, Equipment Validation, PCR

Industry

Herstellung medizinischer Geräte

Description

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 Werfen. 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. 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 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. Qualifications 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. Quality Control Technologist III-Stability Closing If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. 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 NAtalentacquisition@werfen.com for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. www.werfen.com

Responsibilities

This role serves as the subject matter expert for product stability, involving writing protocols, performing testing, and trending stability data, while also acting as a Team Lead to guide QC staff and assist management with daily laboratory operations.