Zoetis, Inc

The QA Manager/TL is accountable for ensuring cGMP compliance within the site's B1 Biological ABI/BPM/ Pharmaceutical and Pharma/Biopackaging Operations, is expected to identify and escalate areas of risk, provide guidance and support in the interpretation and enforcement of regulatory guidelines, and support site project initiatives.. Primary responsibilities include: assistance with area batch record reviews and applicable product release, participation in the Change Management, Investigation, and CAPA systems, maintaining the site's compliance with Zoetis Quality standards, review and approval of action items, performing internal audits and support and quality oversight of ABI/BPM/Pharmaceutical manufacturing, and all packaging operations within Zoetis Lincoln Operations.. Provide QA support for product process validation activities for ABI/BPM/ Pharmaceutical and packaging operations. Demonstrated knowledge of the Deviation (ETS), Change Control (ETS), ValGenesis, ERP (SAP) and Laboratory Information Management (LIMS) systems.. Previous experience with batch record review, process deviation investigations, and change control.

quality assurance manager

Zoetis is the world's largest Manufacturer and Supplier of Animal Pharmaceuticals. At Zoetis in Lincoln, NE, we manufacture high quality medicines for dogs, cats, and livestock. Our plant has been recognized as one of the Nebraska's Safest Companies, with a long-standing presence in Lincoln and we continue to grow. Benefits Include: Great Health Benefits from day 1! 4 weeks accrued paid vacation and 13 paid holidays 401(k) match with company profit sharing Tuition reimbursement Student Loan Repayment Program Position Summary The QA Manager/TL is accountable for ensuring cGMP compliance within the site's B1 Biological ABI/BPM/ Pharmaceutical and Pharma/Biopackaging Operations, is expected to identify and escalate areas of risk, provide guidance and support in the interpretation and enforcement of regulatory guidelines, and support site project initiatives. Primary responsibilities include: assistance with area batch record reviews and applicable product release, participation in the Change Management, Investigation, and CAPA systems, maintaining the site's compliance with Zoetis Quality standards, review and approval of action items, performing internal audits and support and quality oversight of ABI/BPM/Pharmaceutical manufacturing, and all packaging operations within Zoetis Lincoln Operations. This position will lead a team of compliance specialists (currently 3), OTE colleagues (currently 2), and support all associated activities. Taking a leadership role in the Quality Unit, working with internal and external groups, independently prioritizing areas of quality concern and addressing with limited manager intervention. Ability to organize resources and address complex quality decisions independently and efficiently. Communicate effectively and decisively with manufacturing team members as well as members of site management. Work with a team to meet site objectives. The QA Manager/TL will also interface directly with regulatory agency, customers, and internal auditors, provide support for market action activities, and will assist in the identification and communication site and department metrics. Position Responsibilities <ul><li>Provide QA support for product process validation activities for ABI/BPM/ Pharmaceutical and packaging operations </li><li>Ensures cGMP compliance within the Biological and Pharmaceutical Operations systems </li><li>Interpretation and enforcement of FDA, USDA, EU, and other regulatory guidelines </li><li>Provides guidance and support within cGMP systems for site colleagues </li><li>Support regulatory agency, customer, and internal audits </li><li>Review and approval of action items / commitment tracking items </li><li>Review and approval of investigation and interim reports </li><li>Technical writing expertise </li><li>Root Cause Analysis (RCA) expertise; train colleagues in RCA </li><li>Track site wide deviation metrics and establish Key Performance Indicators </li><li>Develop policies to identify and reduce deviations due to previously identified root causes </li><li>Site subject matter expert for implementation and adherence to the quality management system for deviations. </li><li>Support market action activities </li><li>Perform internal audits </li><li>Batch record review, intermediate product release </li><li>Participation in change management activities </li><li>Assist in the review and assessment of Zoetis Quality Standards (ZQS) </li><li>Collection and communication of site and department metrics </li><li>Maintain department Standard Operating Procedures (SOPs) </li><li>Other responsibilities as assigned </li> </ul>Education and Experience B.A. or B.S. in Sciences or related field and at least 10 years of relevant experience. M.S. degree is preferred. Technical Skills and Competencies Required Minimum Qualifications : <ul><li>Risk Management </li><li>Investigation and Problem Solving </li><li>Demonstrated technical capabilities </li><li>Ability to establish appropriate timelines to meet key milestones under minimal supervision </li><li>Deep knowledge of local, federal, and international regulations </li><li>Knowledge of human error awareness / prevention </li><li>Organization skills </li><li>Verbal and written communication skills (fluent in English) </li><li>Works effectively in a team-based environment </li><li>Ability to communicate effectively with Team Members to facilitate completion requests and review from all levels to meet all deadlines </li><li>Proficient in Microsoft Office applications </li><li>Attention to detail </li><li>Demonstrated ability to work with internal and external colleagues </li><li>6-sigma, lean or statistical skills </li> </ul>Preferred Qualifications : <ul><li>Previous experience with methods in biologicals and/or pharmaceutical manufacturing and packaging </li><li>Demonstrated knowledge of the Deviation (ETS), Change Control (ETS), ValGenesis, ERP (SAP) and Laboratory Information Management (LIMS) systems. </li><li>Experience in change management processes, manufacturing operations, quality operations, and/or regulatory affairs. </li><li>Previous experience with batch record review, process deviation investigations, and change control. </li> </ul>Physical Position Requirements <ul><li>Lift materials up to 40lbs </li><li>Ability to sit, stand and walk </li><li>Some travel may be required </li> </ul>Full timeRegularColleagueAny unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search. Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis. #J-18808-Ljbffr

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