QA Specialist II (M-F 1st or split shift)
Aldevron is an industry pioneer with a core competency in manufacturing for gene and cell therapy. We supply high-quality plasmid DNA, mRNA and proteins to our clients, who are breaking new ground on the world’s most important and challenging solutions to benefit us all. We're looking for innovative, forward-thinking individuals who share our goals of advancing science and making an impact on the world.
Aldevron is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
This position is part of the Quality Assurance department located in Fargo, ND and will be onsite working a first shift position. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Quality Assurance Team and report to the Operational Quality Assurance Manager.
Job Summary:
The primary responsibilities of this role will be to interface with other members of the Quality Assurance (QA) team, Quality Control (QC), and Operations to complete review of manufacturing and quality control documentation in order to disposition materials. This individual will perform timely reviews of all batch documentation; assure that batch records are complete, correct, and meet all current Good Manufacturing Practices (cGMP) and all current Good Documentation Practices (cGDP); and confirm all critical process parameters (CPPs) and critical quality attributes (CQAs) have been met to assure patient safety and product quality are protected. Upon completion of review, this individual will determine if the evidence supports release and if the materials are suitable for use and shipping.
In this role, you will have the opportunity to:
- Complete the timely and thorough review of assigned batch documentation and release deliverables for completeness and accuracy. This individual must be able to determine if the data supports release and verify that patient safety and product quality are protected in support of release.
- Serve as the Quality expert and ensure any product that does not meet specification is dispositioned appropriately
- Work with staff across multiple departments during review, correction, and finalization of documentation
- Effectively communicate decisions and rationale utilized review and approval of manufacturing, quality control, and release documentation internally and to the client. Communicate issues, events, and resolution with internal and external clients
- Assists with training of other individuals within the department on specific tasks
- Responsible for tracking and trending documentation errors. Responsible for tracking personal metrics associated with timelines and performance goals
- Promptly escalates all quality and safety issues related to in-process materials and final products.
The essential requirements of the job include:
- Bachelor of Science (Life science related preferred). Equivalent experience may be considered.
- 2+ years of experience in a Quality or auditing role. If experience is in an equivalent GMP facility (biotech, pharma, medical device, etc.),
- Experience working in a regulated or GMP compliant environment
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.