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.
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.
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.
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.
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.
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.
Establishes systems to assure the audit readiness of all testing documentation by regulatory agencies and internal auditors.
Implements strong communication networks for information flow to and from the plant sites, senior management, staff groups and regulatory agencies.
Ensure compliance between current testing practices and the regulatory filings through a Regulatory Compliance self-inspection program.
Actively engage to support location leadership and site leadership initiatives.
Demonstrates a passion for Colleague Engagement and is an active change agent.
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.
Strong written and oral communication skills
Familiarity with statistical analysis and strong problem-solving skills
Strong technical writing skills
Knowledge of USDA, EU, and Animal Welfare Act guidelines
Physical Requirements
Must be able to walk, sit, or stand for long periods of time.
Must be able to reach above shoulder level, bend/stoop, kneel, push/pull, and handle/grip frequently.
Must be able to work scheduled 40 hours with the ability to work overtime as needed.
Must be able to work weekends as needed.
Frequent lifting and carrying of 5 to 25 lbs.
Regular reaching, bending, stooping, and twisting.
Repetitive motion and substantial movement of the wrists, hands, and/or fingers.
Ability to grasp and manipulate objects like pipettors, flasks, and bottles.
Flexibility to cover rotating weekend duties.
Full time
Regular
Colleague
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