Regulatory Compliance Associate-Specialist - Quality Operations

Zoetis•Lincoln, NE

2d•Onsite

About The Position

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. 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.

Requirements

Bachelor's Degree preferred.
Minimum 3 years' relevant experience. Job level based on years of relevant experience and working regulatory knowledge.
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
For the GJL 060-1 level: Greater than 3 years of experience at Associate Staff level position in Manufacturing or Quality Operations
For the GJL 060-2 level: Greater than 3 years of experience at a Staff level position in Manufacturing or Quality Operations
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

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.