Operational Quality Assurance Lead

At Aldevron, we shape the future of medicine by advancing science in meaningful ways.
Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide.
We believe people are our most valuable asset.
Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.
Aldevron is one of 10 Life Sciences companies of Danaher.
Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
This is a senior level position in Operational Quality Assurance (OQA) 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 Manager, Operational QA.
The OQA Lead activities include but are not limited to training, mentoring, and coaching lower level OQA associates and driving coordination of real time review activities.
In collaboration with supporting teams, OQA Lead will ensure review of manufacturing and quality control documentation, disposition of materials and provide real-time operational oversight.
This individual may also be called upon to support the audit team and be used as a subject matter expert to provide answers to client questions regarding Standard Operating Procedures.
In this role, you will have the opportunity to: Cross functional support including gap analysis, FMEA, risk assessments, root cause analysis, tracking and trending, statistical modelling (linear regression, T-test, control charts, etc.
), and develop/maintain client specific process datasets, as needed.
Able to follow, revise, and edit SOPs and forms to confirm compliance to a standard.
Coordination and responsibility for collaboration with Manufacturing in respect to any Quality related actives identified during manufacturing.
Perform GMP oversight, and “real time” review of manufacturing documentation including batch records and protocols during execution.
Monitor and auditing processes to ensure protocols are being met.
This role performs timely reviews of all batch documentation; assure that batch records are complete, correct, accurate, and satisfy all current Good Manufacturing Practices (cGMP) and all current Good Documentation Practices (cGDP) expectations.
Release manufacturing rooms following required reviews and after confirming acceptance criteria have been met.
Oversee label generation to ensure traceability of final material.
Interfaces with technical operations to develop an understating of the critical process parameters associated with manufacturing deviations that can impact product Quality, Safety Purity, or Effectiveness.
Provide technical Quality oversight to manufacturing Quality Events investigations.
Interface with regulatory agencies and customers to provide timely documentation Perform evaluations of proposed changes to the manufacturing process, materials, components, or records to determine the effect on the manufactured product.
Recommendations to correct, enhance, improve, or optimize any underperforming process & creating and amending work instructions, as needed The essential requirements of the job include: 5+ years of experience in a Quality or auditing role.
If experience is in an equivalent GMP facility, such as biotech, pharma, medical device manufacturing, etc.
Experience working in a regulated or GMP compliant environment.
Current or past Quality or auditing certifications a plus (e.
g.
, ISO 9001, ASQ registered inspector, certified internal auditor, etc.
) Bachelor of Science, preferred, life science related field preferred, or equivalent experience.
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.