Job Information
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
We are looking for a Biological Quality Assurance (BQA) Technician III to join our QA team. The Biological Quality Assurance Technician III is responsible for Performing a variety of tasks and functions associated with the appropriate day-to-day operations of the Technical Specialist division within the Quality Laboratories.
Ensure strong GMP environment within a very dynamic and changing manufacturing/quality environment. Achieve compliance ready state of each laboratory area. This includes but not limited to the coordination of training, new and incumbent employees on equipment, documentation, product control, product handling, storage, environmental monitoring and any other task associated with making sure the products reach the customers. Assist with review and approving of test data, trending environmental monitoring data, writing, reviewing and creating SOPs and OJTs. Overseeing and assisting with special projects
This position is not eligible for sponsorship for work authorization. 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 Technical Specialist – QA - Healthcare
Responsibilities
Key Accountabilities:
- Reviews data generated by the BQA Department.
- Ensures all department employees follow applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Blood borne pathogens and chemical hazards).
- Assists Biological Quality Assurance Supervisor in assessing compliance gaps and implementing corrective actions as needed.
- Ensures employee training is documented and completed in a timely manner and that appropriate records of training and evaluation are maintained.
- Performs laboratory tests in BQA when necessary.
- Assists Biological Quality Supervisor in assigning tasks to BQA personnel based on priorities defined by the Production Schedule.
- Assists Biological Quality Supervisor in collecting monthly departmental metrics and quarterly metric data for Quality review or management review meetings.
- Ensures microbiological testing, investigation and documentation is performed in a timely manner to support investigations.
- Performs data entry of test results into database.
- Performs and interprets calculations as needed.
- Performs all assigned tasks following applicable laboratory SOPs, OSHA regulations and cGMP regulations (i.e. Blood borne pathogens and chemical hazards).
- Performs and reports investigations for customer complaints.
- Assists with sample collection, testing, data collection and interpretation for validation protocols and study protocols as assigned.
- Follows aseptic technique in controlled areas.
- Initiates and completes assigned technical projects.
- Initiates and completes technical reports.
- Performs other duties as assigned by the BQA Supervisor or Director.
Biological Quality Assurance Technical Specialist – QA - Healthcare
Qualifications
Minimum Knowledge & Experience required for the position:
- Bachelor’s degree/Science (BS/BA) from four-year college or university; or equivalent combination of education and experience.
- 1+ years’ experience in a highly Regulated/GMP environment
- 3-4 years of experience in Environmental Microbiological laboratory setting including experience in laboratory techniques
Biological Quality Assurance Technical Specialist – QA - Healthcare
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
