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QA Manager

Company: Avantor
Location: Paris
Posted on: May 15, 2022

Job Description:

Job SummaryUnder limited direction, direct the activities for the quality organization for their respective facility. Manage, organize, oversee and ensure the objectives of the QA/QC function are implemented in line with Corporate, site quality and business goals. Develop, manage, and maintain the quality management system to meet applicable regulatory requirements (FDA CFRs, U.S, and international regulations) and international quality standards; ensure products meet customer quality expectations and requirements. Develop, monitor and manage approved departmental budget. Ensure timely closure of all non-conformances, failure investigation reports and corrective/preventive actions; develop strategies for continuous improvementWhy Avantor?

  • Full-Time Health Benefits on Your First Day
  • Competitive Time off Package (PTO and Holidays)
  • Employee Stock Options
  • Retirement Plan Options with company match
  • Direct Hire
    What does the position do?
    • Oversee writing, revision, implementation and training of standard operating procedures and work instructions.
    • Ensures Quality System Requirements are met.
    • Identify staff development needs in area such as training, technical skills, and safety.
    • Communicate with customers regarding quality related issues and complaints.
    • Review test results for raw material, in-process and final product samples.
    • Evaluate and implement new test methods as appropriate.
    • Interpret and apply evolving regulatory and Quality standards.
    • Interact as required with supply partners: raw materials, filtration, testing, and gamma irradiation.
    • Demonstrate strong presentation skills including the ability to prepare and deliver professional presentations to external business interests.
    • Responsible for Batch review and approval, C of A creation, and CAPA process.
    • Provide technical and quality operations support to other departments and contract manufacturers.
    • Drive efficiency, practices and policies that improve quality.
    • Analyze trends to improve quality and allocate resources to drive continuous improvement.
    • Provide direction to Senior Process Engineers located in Coimbatore, prioritizing projects, assigning tasks, establishing completion dates and ensuring projects are completed on time.
    • Review processing documentation/records and create Certificates of GI and HI as requested.
    • Represent VWR Seradigm during Customer Audits. Coordinate timely responses to customer audit findings.
    • Investigate and ensure appropriate root cause analysis is performed and effective CAPA implemented in response to Customer Complaints.
    • Manage Seradigm's Document Control system within the EtQ system.
    • Establish None Disclosure Agreements in conjunction with VWR legal to support business needs.
    • Maintain USDA Exporting Warehouse approval for Caseyville warehouse and BioArra.
    • Assist VWR Sales team by maintaining and revising product specifications as directed.
    • Provide leadership and mentorship to BioArra quality team.
    • Performs other duties as assigned.
      What do you need to have?
      • BS degree in a scientific field such as chemistry, biochemistry or molecular biology
      • 5+ years of applicable work experience
      • 3+ years experience in serum industry
      • 3+ years experience in quality, auditing and/or project management,
      • Demonstrated experience and working knowledge of cGMPs and associated guidelines regulatory guidelines for the manufacture, testing and release of serum related products
      • Ability to work successfully both independently and in a team environment
      • ISIA certification
        What would be nice to have?
        • Strong written and verbal communication skills
        • Strong analytical skills
        • Advanced skills in MS Office products including Excel, Visio and PowerPoint
        • Ability to lead cross functional teams to execute on complex tasks in a growing and changing environment
        • Knowledge and skills in root cause analysis and the CAPA process
        • Demonstrated working with integrity and intensity
        • Demonstrated entrepreneurial capability while working within a large company
          What's the environment like?
          • The work environment characteristics and physical effort described here are representative of those associate encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities.
          • While performing the duties of this job, the associate is exposed to an industrial warehouse environment.
          • The associate works near moving mechanical machinery and noise level in the work environment is usually loud.
          • The job requires working in heights, exposure to changes in temperature, driving equipment, and maybe exposed to dust, fumes, or gases.
          • The associate is required to stand and walk for the majority of the working day. The physical requirements of the job are for associates to talk, hear, bend/stoop, squat, crawl, climb height, reach above shoulder height, crouch, kneel, balance, and push/pull.
          • Furthermore, the job requires associates to lift/carry/push or pull up to 75 pounds with or without assistance.
          • Associates use both hands for repetitive actions such as grasping and manipulating as well as both feet for repetitive movement operating foots controls. Specific vision abilities required by this job include close vision, peripheral vision, depth perception, and the ability to adjust focus.
          • Each employee is responsible to perform their defined tasks to maintain the site's certifications and follow all regulatory requirements.
          • The employee is expected to shut down the operation and notify management if an unsafe condition is observed or an instance of regulatory non-compliance that requires immediate attention arises.
          • Regulatory requirements include, but are not limited to cGMPs, EPA, OSHA, DEA, DOT, and any other applicable local, governmental and company guidelines
          • Meet minimum training requirements for RCRA Hazardous Waste Management (40 CFR 262.17(a)(7)) within 6 months of employment, and re-train as required by the Kentucky DEP and US EPA hazardous waste regulationsDISCLAIMER:
            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 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.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.

Keywords: Avantor, Lexington , QA Manager, Executive , Paris, Kentucky

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