Document Control Specialist - Day Shift - Casa Grande, AZ

RXinsider LTD.; Casa Grande (AZ); On-site; USD 26,243 - 52,555; Full time

Benefits offered by this job

Health plan

Retirement plan

Tuition reimbursement

FreeU education

Job summary

Abbott Nutrition plant in Casa Grande, AZ is seeking a Document Control Specialist to support and maintain the Quality System and ensure timely product release. The role involves coordinating batch release criteria, handling exception reports, and ensuring regulatory compliance across QA activities.

Based in Casa Grande, you will work with DQA, PR&D, and contract manufacturers to uphold FDA and IFA standards, maintain records, and support audits and training.

Qualifications

• High School Diploma or GED required.
• 2+ years of Quality Assurance experience in a regulated environment.
• Knowledge of regulatory standards for infant formula and nutritional products.
• Familiarity with manufacturing processes, including analytical, processing, and filling operations.
• Understanding of FDA and IFA regulations.
• Strong analytical and problem-solving skills with attention to detail.
• Effective written and verbal communication skills.
• Proficiency in computer systems and applications; ability to prioritize and manage workload.

Responsibilities

• Establish and communicate batch release criteria with DQA, PR&D, and third-party manufacturers.
• Initiate and manage Exception Reports (ERs) and Plant Information Reports (PIRs).
• Enter, maintain, and review work orders, ERs, and SQEs in the Release Batch Activity system.
• Utilize CAMBAR and AMAPS to manage and verify batch release status.
• Perform final batch record review to ensure regulatory compliance prior to approval.

Skills

Quality Assurance

Regulatory knowledge

Analytical skills

Documentation control

Communication

Education

High School Diploma or GED

Tools

CAMBAR

AMAPS

GQMS

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 115,000 colleagues serve people in more than 160 countries.

Document Control Specialist - Casa Grande, AZ Nutrition Plant

Position Summary

Responsible for supporting and maintaining the effectiveness of the Quality System, ensuring compliance with regulatory requirements and timely product release.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to :

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Casa Grande, Arizona location in the Abbott Nutrition division.

Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® – to help them get the nutrients they need to live their healthiest lives.

Casa Grande, AZ., is one of Abbott’s leading nutrition manufacturing plants in the U.S., reflecting our commitment to innovation and excellence. But we’re more than just a company, we’re a family. Working here you’ll be part of a family that works together to make a difference and enhance the lives of millions worldwide.

What You’ll Work On

• Establish and communicate batch release criteria in collaboration with DQA, PR&D, and third-party manufacturers, including documentation requirements and audit findings.
• Initiate and manage Exception Reports (ERs) and Plant Information Reports (PIRs), ensuring proper routing and disposition.
• Enter, maintain, and review work orders, ERs, and Standard Quality Evaluations (SQEs) within the Release Batch Activity (RBA) system.
• Utilize systems such as CAMBAR and AMAPS to manage and verify batch release status.
• Perform final batch record review to ensure compliance with regulatory requirements prior to submission for approval.
• Coordinate isolation, hold, rework, and release activities, ensuring all discrepancies and deviations are resolved and properly documented.
• Maintain accurate records, including non-batch documentation such as storage temperature logs.
• Reconcile production output with inventory and track/report quality metrics.
• Enter corrections and corrective action plans into GQMS.
• Support surveillance testing programs, including coordination, documentation, and product impact assessments.
• Communicate batch release timing to meet production and shipment goals.
• Assist with preparation of Certificates of Analysis.
• Support audits, training, and onboarding of new or contract employees.
• Partner with supervisors and cross-functional teams to address quality issues and meet business needs.

You’ll be accountable for meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.

Shift - 8 :00am - 5 :00pm; Monday - Friday (subject to change due to the needs of the business)

Required Qualifications

• High School Diploma or GED
• 2+ years of Quality Assurance experience in a regulated environment
• Knowledge of regulatory standards for infant formula and nutritional products
• Familiarity with manufacturing processes, including analytical, processing, and filling operations
• Understanding of FDA and IFA regulations
• Strong analytical and problem-solving skills with attention to detail
• Effective written and verbal communication skills
• Proficiency in computer systems and applicationsAbility to prioritize and manage workload to meet deadlines

The base pay for this position is $19.05 – $38.15 per hour. In specific locations, the pay range may vary from the range posted.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives : www.abbottbenefits.com

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

Abbott is an Equal Opportunity Employer and a Military/Veteran friendly Employer, committed to employee diversity.