Quality Assurance Compliance Specialist

Zoetis•Lincoln, NE

16h•Onsite

About The Position

This position provides Quality Assurance support for Lincoln manufacturing operations, supporting the biological and biopharmaceutical manufacturing process teams. This position is responsible for providing on-the-floor Quality Assurance support functions for antigen and monoclonal antibody production by performing for real-time batch record review, quality assessments, deviation decisions and change control activities. This position will also interface directly with regulatory agency, customers, and internal auditors, and provide support with site and department metrics. This position reports to the B2 Quality Assurance Team Lead, and will work closely with Manufacturing, Materials Management / Production Scheduling, Quality Operations laboratories, Regulatory and Site Leadership.

Requirements

Associates degree
Minimum 3-5 years of progressive experience at the OTE Lead level or above, in Manufacturing or Quality Operations
Bachelor’s degree
Greater than 4 years’ experience at an Associate Staff level position in Manufacturing or Quality Operations.
Investigation and Problem Solving
Demonstrated technical capabilities.
Ability to establish appropriate timelines to meet key milestones under minimal supervision.
Knowledge of local, federal, and international regulations
Knowledge of human error awareness / prevention
Organization skills
Verbal and written communication skills (fluent in English)
Works effectively in a team-based environment
Ability to communicate effectively with Team Members to facilitate completion requests and review from all levels to meet all deadlines.
Proficient in Microsoft Office applications
Attention to detail.
Demonstrated ability to work with internal and external colleagues.

Nice To Haves

Previous experience with manufacturing methods for antigen production, media preparation, or monoclonal antibody processes.
Demonstrated knowledge of the Deviation (ETS), Change Control (ETS), ERP (SAP), and Laboratory Information Management (LIMS) systems.
Experience in change management processes, manufacturing operations, quality operations, and/or regulatory affairs.
Previous experience with batch record review, process deviation investigations, and change control.

Responsibilities

Perform routine batch record review and product release functions for assigned support areas within established timelines (e.g. at the end of the shift), ensuring compliance with all applicable regulatory requirements and product registrations.
Support, review and approve deviation investigations, ensuring documentation meets internal and regulatory requirements, is completed within established timelines, and identifies root cause.
Review and approve corrective / preventive actions, ensuring effectiveness of identified actions and completion within identified timelines.
Review and approve change control for manufacturing documents and procedures, ensuring compliance with applicable regulatory standards.
Provide QA support for product transfers and process improvement initiatives.
Review and approve validation protocols and reports.
Perform internal audits of manufacturing operations to ensure compliance with corporate and GMP/ regulatory requirements.
Perform inspection readiness activities and provide QA support during Corporate and Regulatory inspections.
Other responsibilities as assigned.