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Quality Release Supervisor at ALDEVRON, LLC

Posted in Science 30+ days ago.

Type: Full-Time
Location: Fargo, North Dakota





Job Description:

The Quality Release Supervisor is a working position that will work daily with Aldevron’s QA Release, Operational QA and Quality Inspecting teams.  The Quality Release Supervisor is expected to be familiar with all of Aldevron’s products and how it correlates to the review of batch records and testing results in support of releasing final material.

Responsibilities

In addition to QA Specialist II duties:


  • Responsible for oversight of QA Specialists’ daily work instructions in support of review of manufacturing/testing records and release of Aldevron products

  • Ensures all reporting and applicable metrics are populated as assigned

  • Responsible for maintaining quality assurance standards, processes and controls. Develops and implements methods for inspection, testing, sampling, and training

  • Maintain a team environment

  • Support quality assurance programs, processes and facilities by ensuring compliance with regulatory, internal and client requirements in the manufacture of products

  • Identify compliance risks at Aldevron through auditing process

  • Support of Aldevron’s record review program to ensure processes are performed in accordance with written procedures and other applicable external requirements and appropriately and adequately identifying and prioritizing internal risks, ensuring deficiencies are addressed in real time.

  • Support Clinical Manufacturing activities by: 

    • Perform technical and administrative review of batch and analytical data for accuracy and compliance with procedures in support of product release 

    • Oversight of room/equipment release for usage as it relates to batch review and release

    • Perform technical and administrative review of qualification documents for accuracy and compliance with procedures in support of releasing for use, as required

    • Review and approve QC product testing documentation and Certificate of Analysis supporting batch release 

    • Issuance of Certificates of Analysis



  • Maintain efficient operations and continual process improvements. Identify ways to optimize processes and job execution that improves workflow and reduces timelines

  • Contribute to reviewing and updating SOPs, forms and report templates.

  • Identify problems that may adversely affect final material, takes authorized corrective action, and notifies management

  • Oversee QA Specialists personnel to ensure following established standard operating procedures and meeting timelines

  • Manage shift-to-shift communications

  • Assign responsibilities, establishes work hours, and monitors staffing performance. Provides feedback to Management regarding performance and assists with performance reviews. The Supervisor may also assist with employee interviews and orientations as needed

  • Ensure release of equipment/assays and final material is done within a timely manner to prevent delays to the manufacturing schedule

  • Complete training and job coaching with staff to help them fulfil and exceed the requirements of their job

  • Execute CAPAs and deviations within defined timelines

  • Communicate the status of operations, process issues, and safety and maintenance issues to Management

  • Perform data entry and peer review of quality documents for accuracy in accordance with laboratory procedures, standards and GMP requirements

Required Skills


  • Experience working within a GMP environment, under a Quality System

  • Knowledge of GMP regulations related to production of biopharmaceuticals and molecular diagnostic controls

  • Knowledge of ISO certification and requirements 

  • Good communication skills as needed for reporting, documentation, and scheduling

  • Following written procedures and written and verbal directions

  • Good knowledge of computers and programs

Must-Haves


  • 3 years or more related experience in Quality Assurance

  • B.S. (or equivalent) degree in science or related field preferred, but not required

Physical Requirements

While performing the duties of this position, the employee is regularly required to see, talk and hear. The employee frequently is required to stand, walk, bend, lift up to 30 pounds, and use arms, hands and fingers for various activities. This position may stand or remain sedentary for long periods of time.  

Join Us Today!

Join a team committed to making lives better. Aldevron provides high-quality plasmid DNA, proteins, enzymes, antibodies, and other biologics to help our partners achieve significant breakthroughs for a variety of life science applications.

If you would like to thank someone for referring you to this role, please apply at www.aldevron.com/careers, and include their first and last name as a referral source!

Aldevron is committed to equal opportunity for all employees and applicants. We are committed to creating a diverse workforce and consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identify, or protected veteran status among other factors.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

See job description





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