Quality Assurance Associate Compliance Specialist

Zoetis•Lincoln, NE

2d•Onsite

About The Position

Zoetis is hiring a Quality Assurance Associate Compliance Specialist to support its Lincoln, Nebraska manufacturing operations, specifically biological and biopharmaceutical manufacturing teams. The role provides on-the-floor Quality Assurance support for antigen and monoclonal antibody production, including real-time batch record review, quality assessments, deviation decisions, and change control activities. It 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 the first shift. The job level depends on relevant experience: the 040-1 level requires an associate degree and 3–5 years of progressive experience at the OTE Lead level or above in Manufacturing or Quality Operations; the 040-2 level requires a bachelor's degree and more than 4 years' experience at an Associate Staff level in Manufacturing or Quality Operations.

Requirements

For the 040-1 grade level: associate degree and 3–5 years of progressive experience at the OTE Lead level or above in Manufacturing or Quality Operations.
For the 040-2 grade level: bachelor's degree and more than 4 years' experience at an Associate Staff level in Manufacturing or Quality Operations.
Investigation and problem-solving skills.
Demonstrated technical capabilities.
Ability to establish appropriate timelines and meet key milestones with minimal supervision.
Knowledge of local, federal, and international regulations.
Knowledge of human error awareness and prevention.
Strong organizational skills.
Verbal and written communication skills, with fluency in English.
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 weighing up to 40 pounds and to sit, stand, and walk.
Authorization to work in the United States for Zoetis; candidates requiring sponsorship must disclose this.

Nice To Haves

Previous experience with manufacturing methods for antigen production, media preparation, or monoclonal antibody processes.
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 regulatory requirements and product registrations.
Support, review, and approve deviation investigations; ensure documentation meets internal and regulatory requirements, is timely, and identifies root cause.
Review and approve corrective and preventive actions, ensuring their effectiveness and timely completion.
Review and approve change control for manufacturing documents and procedures in accordance with applicable regulatory standards.
Provide Quality Assurance support for product transfers and process improvement initiatives.
Review and approve validation protocols and reports.
Perform internal audits of manufacturing operations for compliance with corporate, GMP, and regulatory requirements.
Perform inspection-readiness activities and provide Quality Assurance support during Corporate and Regulatory inspections.
Carry out additional responsibilities as assigned.