Regulatory Compliance Associate-Specialist - Quality Operations

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 the Lincoln community. We are a clean, modern site that continues to innovate and grow. Benefits Include: 4 weeks accrued paid vacation and 13 paid holidays. 401(k) match with company profit sharing. Tuition reimbursement and Student Loan repayment program. Great Health, personal, and family benefits starting day 1. Position Summary This position will conduct US domestic and international regulatory compliance activities for Lincoln Operations with emphasis on USDA, DEA, and FDA activities. This will include registration change controls and annual compliance reviews. This position will provide support to the DEA Compliance Liaison. Hours: 1st Shift. Occasional extended hours/weekend work. Position Responsibilities · Management of biological registration change control, including annual outline of production review, outline update, including regulatory change requests and submission action requests. This will include Outline submissions, regulatory communications, and revisions. · The position will require a thorough knowledge of 21CFR for controlled substances and will provide support for activities associated with DEA compliance, including quarterly audits and compliance management. · Support annual administrative inspection review, market actions, and recalls. · This position will manage GMS facility documents, including blueprints and legend updates periodically for multiple GMS sites. · Perform data collection for Annual Product Reviews: Biological and Pharmaceutical products. Including trending of market actions, rework, recalls, and regulatory notifications to the USDA. · Maintain a thorough knowledge of APHIS/USDA/FDA/EU regulatory requirements associated with the testing and manufacture of veterinary biological and pharmaceutical products. · Participate on key teams to address quality issues and project improvements. · Advise management of regulatory deficiencies and recommend actions when products do not meet GMS or government requirements. · Ensures all Outlines of Production are compliant with contemporary USDA standards, 9 CFR 114, and VSM 800.206. · Interpretation and enforcement of 9CFR, 21CFR, EU and other regulatory guidelines · Support regulatory agency, customer, and internal audits. · Participation in change management activities · Maintain department Standard Operating Procedures (SOPs) · Other responsibilities as assigned. Education and Experience · Bachelor's Degree preferred. · Minimum 3 years' relevant experience. Job level based on years of relevant experience and working regulatory knowledge. o For the GJL 040-2 level: Minimum 3-5 years of progressive experience at the OTE Lead Level or above in Manufacturing or Quality Operations o For the GJL 060-1 level: Greater than 3 years of experience at Associate Staff level position in Manufacturing or Quality Operations o For the GJL 060-2 level: Greater than 3 years of experience at a Staff level position in Manufacturing or Quality Operations Technical Skills and Competencies Required · Demonstrated ability to write and review technical documents with high attention to detail. · Ability to establish appropriate timelines to meet project milestones under minimal supervision. · High integrity and self-motivation. · Proven project management skills and organization · Ability to develop solutions to routine problems following procedures. · Demonstrated organizational and administrative skills, in addition to proven skills in multitasking and prioritizing projects in support of standard work. · Strong communication (oral and written) with ability to communicate effectively with Team Members to facilitate completion requests and review from · Demonstrated ability to identify issues. · Thorough knowledge of USDA/FDA/EU regulatory requirements associated with the testing and manufacturing of veterinary biological and pharmaceutical products. · Demonstrated ability to work with internal and external colleagues. · Experience with MS Word, Excel, Outlook, Trackwise, LIMS, Veeva Vault and SAP Physical Position Requirements · This position requires sitting, standing, and walking with occasional extended hours/weekend work. Full time Regular Colleague Any 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. Notice: Zoetis Recruiters will contact candidates via email from an address ending in @zoetis.com and may also initially connect with candidates through LinkedIn , including LinkedIn InMail. Zoetis does not use Gmail, Outlook, Yahoo, or other web-based/generic email domains to communicate about job opportunities, interviews, or offers of employment. If you receive a recruitment-related email message claiming to be from Zoetis that does not come from @zoetis.com , please treat it as suspicious. For your security, do not reply, click links, open attachments, share personal or financial information, or send money in response to unexpected or questionable recruitment communications. 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 [email protected] 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 www.Zoetis.com/careers 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.