Biological Quality Assurance Technician - Transfusion at Werfen GmbH

Norcross, Georgia, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Jun, 26

Salary

0.0

Posted On

08 Mar, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Microbiological Testing, Environmental Sampling, Aseptic Technique, Culture Incubation, Gram Stain, Data Entry, SOP Revision, Facility Qualification, Process Validation, cGMP Regulations, OSHA Regulations, Quality Assurance, Product Sampling, Calculations

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 We are looking for a Biological Quality Assurance (BQA) Technician to join our QA team. The Biological Quality Assurance Technician is responsible performing product and environmenetal sampling for microbiological and environmental testing to confirm the quality of products at Immucor, Inc.for the microbiological testing and environmental monitoring to confirm the quality of products at Immucor, Inc. 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. Biological Quality Assurance Technician (BQA) – QA - Healthcare Responsibilities The BQA Technician will be responsible for performing all assigned tasks following applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Blood borne pathogens and chemical hazards). Responsibilities of the Biological Quality Assurance Technician include: Performs cultures of environmental samples. Performs environmental sampling of controlled environments, including air, water, surface and personnel. Performs cultures of bulk and final product. Incubates, reads and records culture results. Performs and reports gram stain results. Follows asceptic technique in controlled areas. Performs data entry and filing of department paperwork. Performs calculations as needed. Review and revise departmental SOPs and forms as required Support execution of Facility Qualifications and Raw Material/Process Validations as required. Performs other duties as assigned as per the Sr. Manager Quality Operations or BQA Supervisor.Performs cultures of environmental samples. Biological Quality Assurance Technician (BQA) – QA - Healthcare Qualifications Requirements of the Biological Quality Assurance Technician include: Bachelor’s degree (BS/BA) from four-year college or university; or equivalent combination of education and experience. BS degree preferred in Microbiology, Biology, Medical Laboratory Science 1-2 years’ experience in a microbiological laboratory setting including experience in laboratory techniques is preferred, but not required Microbiological or environmental sampling experience and/or general laboratory experience desired Must be able to visualize bacterial culture media to properly inoculate media for testing. Biological Quality Assurance Technician (BQA) – QA - Healthcare 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

The Biological Quality Assurance Technician performs product and environmental sampling for microbiological and environmental testing to confirm product quality, following all applicable laboratory SOPs, OSHA, and cGMP regulations. Key tasks include performing cultures of environmental and product samples, incubating and recording results, performing gram stains, and maintaining departmental paperwork.