Quality Assurance Associate Compliance Specialist

Zoetis; Lincoln (NE); Presencial; USD 70.000 - 100.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Paid vacation

401(k) match

Tuition reimbursement

Health benefits starting day 1

Descripción de la vacante

Zoetis in Lincoln, NE is seeking a Quality Assurance professional to support on-the-floor manufacturing operations, perform batch record reviews, and lead deviation investigations. You will interface with regulatory bodies, customers, and internal auditors to ensure compliance and timely release of products.

Ideal candidates have an associate or bachelor’s degree with 3–5+ years in manufacturing or quality operations, and strong knowledge of GMP, regulatory standards, and QA processes.

Formación

• Investigations and problem solving experience.
• Knowledge of local, federal, and international regulations.
• Strong written and verbal communication in English.
• Ability to work in a team-based environment.
• Attention to detail and organizational skills.

Responsabilidades

• Perform routine batch record review and product release within timelines.
• Support deviation investigations and ensure root cause identification.
• Review and approve corrective/preventive actions.
• Review and approve change control for manufacturing documents.
• Provide QA support for product transfers and process improvements.
• Review validation protocols and reports.
• Conduct internal audits and support inspections.
• Assist with readiness activities during regulatory inspections.

Conocimientos

Investigation and Problem Solving

Verbal and written communication

Microsoft Office

Teamwork

Attention to detail

Educación

Associate degree

Bachelor's degree

Herramientas

SAP

LIMS

ETS (Deviation/Change Control)

Descripción del empleo

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 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. Hours: 1st Shift.

Position 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.
• Additional responsibilities as assigned.

Education and Experience

040-1 grade level

• Associates degree
• Minimum 3-5 years of progressive experience at the OTE Lead level or above, in Manufacturing or Quality Operations

040-2 grade level

• Bachelor's degree
• Greater than 4 years' experience at an Associate Staff level position in Manufacturing or Quality Operations.

Technical Skills and Competencies Required

Minimum Qualifications

• 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

Preferred Qualifications

• 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.

Physical Position Requirements

• Lift materials up to 40lbs
• Ability to sit, stand and walk
• Some travel may be required

Full time Regular Colleague

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 [e-mail] 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.

Why Zoetis

Zoetis has more than 60 years of experience in delivering innovative, high-quality products and services that benefit our customers.

Zoetis work environment

At Zoetis, we take pride in a collaborative spirit and high-performing environment where every colleague is given room to learn and grow.

Your opportunities at Zoetis

We invest in our people and offer diverse and exciting opportunities to make a difference in a growing global industry while shaping the future of animal health.

Results that matter

Our colleagues make an impact by working hand-in-hand with those who raise and care for animals to better understand and address the unique real-world challenges they face.