BQA Technical Specialist Transfusion and Transplant
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Job Location:
Norcross, GA - USA
Monthly Salary:
Not Disclosed
Posted on:
3 days ago
Vacancies:
1 Vacancy
Job Summary
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 7000 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. Were 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 forPerforming 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 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 isnot eligible for sponsorship for work authorization. Therefore if you will require sponsorship from us for work authorization now or in the futurewe 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 Qualityreview 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 aseptictechnique 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:
- Bachelors 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
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 individuals 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 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 7000 employees around the world comprise our Werfen team.
Required Experience:
IC
Key Skills
- Dhcp
- SQL
- Active Directory
- VOIP
- VMware
- Customer Service
- Windows
- Trouble Shooting
- Java
- VPN
- Sharepiont
- hardware
- Dns
- Technical Support
- Software Applications
About Company
Since 1959, we’ve harnessed our passion to create a history of innovative specialized diagnostics breakthroughs in vitro diagnostics, improve the quality of test results, and enhance patient care.
