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IPQA Specialist at ALDEVRON, LLC in Fargo, North Dakota

Posted in Science 30+ days ago.

Type: Full-Time





Job Description:

The IPQA specialist will support Aldevron’s quality system processes and oversee clinical manufacturing operations. This will assure compliance by acting as the primary contact for quality on the production floor.  The IPQA Specialist will be responsible for providing support to manufacturing in the investigation of non-conformances/deviations, providing input related to product quality impact from such events, and providing guidance and assistance with product containment and/or segregation of non-conforming material.

Responsibilities


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

  • Act as a quality representative on the floor during manufacturing operations

  • Support GMP and GMP-S Manufacturing activities by:

    • Performs a real time review of batch and analytical data concurrent with manufacturing operations on the manufacturing floor

    • Oversight of room/equipment release for use

    • Active participation in the Environmental Monitoring program

    • Review and approve Quality Control product testing documentation supporting batch release


  • Write, review, assess and approve quality event investigations and routine environmental monitoring investigations.

  • Create, revise, and review SOP’s to ensure completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.

  • Identifies compliance risks at Aldevron by performing routine quality audits.

  • Coordinates scheduling of line clearance, changeover events and other support activities with the appropriate department management. Reviews and reconciles label generation. Coordinates inspection of final filled product with the appropriate department management and provides oversight of disposition of visual inspection defects.

  • Develops and implements procedures for inspection, testing, sampling, and training activities associated with IPQA responsibilities.

  • Assist with implementation and training of all employees regarding the quality system and overall compliance with the corporate quality manual.

  • Support of the CAPA system by:

    • Ensuring all events are adequately investigated

Required Skills


  • Experience working in aseptic filling operations, media fills, and in clean room environments is preferred. 

  • The ability to work cross functionally within all levels of our team

  • Strong leadership skills

  • Written/Oral communication

  • High attention to detail

  • Strong analytical skills, problem solving techniques and technical skills. 

  • Skilled with Microsoft Office applications

Must-Haves


  • Bachelor’s degree in a Life Sciences discipline or high school diploma with equivalent experience.

  • Minimum 1-2 years of quality experience or demonstrated quality mind set through working in related areas (i.e. manufacturing, engineering, validation, QC, etc.) preferred.

  • A good understanding of molecular biology, biochemistry, and cell biology

Work Hours/Shift

Monday-Friday – 8 am – 5 pm

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.

Experience


Preferred


  • 1 - 2 years: Quality environment

Education


Required


  • High School or better

Preferred


  • Bachelors or better

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