Quality Assurance Associate Compliance Specialist

Zoetis•Lincoln, NE

1d•Onsite

About The Position

This position provides Quality Assurance support for Zoetis’s Lincoln manufacturing operations, supporting biological and biopharmaceutical manufacturing process teams. It provides on-the-floor QA support for antigen and monoclonal antibody production, including real-time batch record review, quality assessments, deviation decisions, and change control activities. The role also interfaces with regulatory agencies, customers, and internal auditors and supports site and department metrics. The position reports to the B2 Quality Assurance Team Lead and works closely with Manufacturing, Materials Management / Production Scheduling, Quality Operations laboratories, Regulatory, and Site Leadership. The role is on 1st shift.

Requirements

For grade level 040-1: Associate degree and a minimum of 3–5 years of progressive experience at the OTE Lead level or above in Manufacturing or Quality Operations.
For grade level 040-2: Bachelor's degree and more than 4 years' experience at an Associate Staff level position in Manufacturing or Quality Operations.
Investigation and problem-solving skills.
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 and prevention.
Organization skills.
Fluent English verbal and written communication skills.
Ability to work effectively in a team-based environment.
Ability to communicate effectively with team members at all levels to facilitate requests and reviews and meet deadlines.
Proficiency in Microsoft Office applications.
Attention to detail.
Demonstrated ability to work with internal and external colleagues.
Ability to lift materials up to 40 pounds and to sit, stand, and walk.
Some travel may be required.

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, ensuring compliance with applicable regulatory requirements and product registrations.
Support, review, and approve deviation investigations, ensuring documentation meets internal and regulatory requirements, is completed on time, and identifies root cause.
Review and approve corrective and preventive actions, ensuring effectiveness 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.
Perform additional responsibilities as assigned.