Position Summary:
Manages all Biological Quality Control Operations for the Charles City site to ensure all vaccines meet US, EU and International regulatory requirements. Advise Management of products not meeting required testing specifications and recommend appropriate regulatory actions when products do not meet Zoetis or government requirements.
Position Responsibilities:
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Oversee day to day activities in the Quality Control laboratories and Animal Test facility. Manages 4 departments within the Quality Control Organization, Virology; Bacteriology and Immunology; Chemistry, Microbiology and Environmental Monitoring; and Animal Test.
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Assures overall quality/integrity of biological products manufactured and distributed in worldwide markets based on 9CFR, applicable cGMP regulations (EU, JP, etc.), and industry standards.
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Ensure all biological products manufactured by or distributed by Charles City are tested according to applicable USDA, EU and Zoetis quality standards, as well as the regulatory requirements of a destination country.
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Responsible for APHIS sampling, APHIS Form 2008 preparation, Stability and Confirmation of Expiry Testing and submissions, LIMS management and test sample distribution.
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Training and Development: Ensure all colleagues are adequately trained and continue to receive training on cGMPs, safety, OSHA, technical skills, policies, and procedures. Ensure training documentation is accurate and only trained colleagues are allowed to perform functions.
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Performance: Use situational leadership skills. Encourage full participation and teamwork. Commit to developing people. Conduct performance appraisals. Create and inclusive environment and promote mutual accountability. Provides leadership for the Quality Operations (QO) Quality Control unit.
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Direct the review of and give QC approval for test records, batch records, process worksheets, Standard Methods, and Standard Operating Procedures (SOPs). Ensure that testing and manufacturing documents follow Outlines of Production. Review and approve validation protocols and task reports, as necessary.
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Work with Quality Control Laboratory personnel, Manufacturing and Planning to organize and prioritize schedules to ensure timely testing and release of all products, i.e. saleable, experimental, stability and transfer.
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Work closely with Biological Manufacturing management to investigate and resolve processing quality and compliance issues by insuring appropriate and expedient testing. Ensure continued regulatory compliance within Charles City by actively participating on key teams and task forces and making appropriate recommendations when needed to assure compliance.
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Advise Management of regulatory deficiencies and recommend appropriate regulatory actions when products do not meet Zoetis or government requirements. Actively participate in regulatory inspections of the Charles City facility.
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Manage the systems that support raw material release, final product release, new product transfers/specifications, APRs, stability, and complaints. Assures that all quality documentation utilized in the manufacture/ testing of biologicals meet cGMP and regulatory requirements.
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Establishes systems to assure the audit readiness of all testing documentation by regulatory agencies and internal auditors.
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Implements strong communication networks for information flow to and from the plant sites, senior management, staff groups and regulatory agencies.
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Ensure compliance between current testing practices and the regulatory filings through a Regulatory Compliance self-inspection program.
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Actively engage to support location leadership and site leadership initiatives.
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Demonstrates a passion for Colleague Engagement and is an active change agent.
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Engaged in monitoring changes in the external regulatory community.
Education and Experience:
BS/BA in science related field with 9-13 years of experience OR MBA/MS in science related field with 7-11 years of experience.
Technical Requirements:
- Proficient in Microsoft Word, Excel, and PowerPoint, with the ability to leverage advanced features for data analysis, reporting, and presentation development.
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Strong written and oral communication skills
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Familiarity with statistical analysis and strong problem-solving skills
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Strong technical writing skills
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Knowledge of USDA, EU, and Animal Welfare Act guidelines
Physical Requirements:
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Must be able to walk, sit, or stand for long periods of time.
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Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
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Must be able to work scheduled 40 hours with the ability to work overtime as needed.
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Must be able to work weekends as needed.
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Frequent lifting and carrying of 5 to 25 lbs.
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Regular reaching, bending, stooping, and twisting.
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Repetitive motion and substantial movement of the wrists, hands, and/or fingers.
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Ability to grasp and manipulate objects like pipettors, flasks, and bottles.
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Flexibility to cover rotating weekend duties.
Full time
Regular
Colleague
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