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Avantor, Inc. QA Supervisor in Morrisville, North Carolina

Job SummaryOversees the Quality System to ensure that industry best practices are implemented and followed with respect to quality assurance, quality control and process improvements. This is accomplished by supervising the Quality Assurance staff.

MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)

  • Maintains all procedures directly related to product and process quality; reviews and approves all corporate procedures that affect the quality system.

  • Oversees a Quality System that is certified to ISO 9001 and/or ISO 13485 and that is compliant with the FDA’s current Good Manufacturing Practices (cGMPs):

  • Implement and/or approve ISO/cGMP operating procedures and work instructions.

  • Resolve internal product and process issues through established non-conformance and Corrective and Preventive Action (CAPA) systems.

  • Address customer complaints in accordance with an effective complaint handling process.

  • Host customer audits and handle customer requests for quality-related information.

  • Interact with the ISO Registrar in matters concerning the company’s Quality System certification status.

  • Owns the incoming material inspection, shelf-life and release program. Works closely with suppliers to improve quality through pre-qualification reviews, on-site audits and performance evaluation and monitoring.

  • Assures that production job packages, finished product documentation (such as Certificates of Compliance), product labeling and inspection/testing processes are robust and implemented in a manner that cGMP, ISO and other regulatory requirements are met.

  • Assures that finished product batch records are complete and accurate (via the batch record review program) and oversees the release of finished product to the customer.

  • Manages the internal audit program, the instrument calibration system, the cGMP training program and the pest control program; ensures all audits and instrument calibrations are completed on schedule.

  • Designs and generates reports, utilizes statistics and metrics, as appropriate, to evaluate trends and to aid senior management in the identification and resolution of quality issues and overall quality improvement efforts.

  • Performs other duties as assigned.

QUALIFICATIONS (Education/Training, Experience and Certifications)

  • Bachelor’s degree or equivalent/applicable experience

  • 5+ years quality assurance experience; at least some experience must be in the medical device or biopharma industries

  • Extensive knowledge of FDA regulations (including cGMPs – 21CFR Parts 820, 210, 211) and ISO 9001 / ISO 13485

KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)

  • Strong communication skills - able to challenge, influence, and articulate the corporate quality mission and drive behavior or action and train employees

  • Self-starter who works with a sense of urgency and acts as a good team player working with other departments

  • Adaptability and resourcefulness to multi-task and thrive in a fast-paced, small-to-mid size organizational environment

  • Resourceful to be problem solver and process improver

ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)

Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level.

Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.

A frequent volume of work and deadlines impose strain on routine basis.

Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.

DISCLAIMER:The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.Avantor is proud to be an equal opportunity employer.

EEO Statement

We are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at TalentManagement@avantorsciences.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision using the links below.

EEO is the Law (https://media.vwr.com/emdocs/docs/EEO-is-the-law.pdf)

OFCCP EEO Supplement (https://media.vwr.com/emdocs/docs/OFCCP-EEO-Supplement.pdf)

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

3rd party non-solicitation policy

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation

Avantor®, a Fortune 500 company, is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. Our portfolio is used in virtually every stage of the most important research, development and production activities in the industries we serve. One of our greatest strengths comes from having a global infrastructure that is strategically located to support the needs of our customers. Our global footprint enables us to serve more than 225,000 customer locations and gives us extensive access to research laboratories and scientists in more than 180 countries. We set science in motion to create a better world. For information visit, www.avantorsciences.com and find us on LinkedIn (https://www.linkedin.com/company/avantorinc/) , Twitter (https://twitter.com/Avantor_News) and Facebook (https://www.facebook.com/Avantorinc/) .

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