Document Control Specialist - Day Shift - Casa Grande, AZ
About The Position
Responsible for supporting and maintaining the effectiveness of the Quality System, ensuring compliance with regulatory requirements and timely product release. 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.
Requirements
- 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 applications
- Ability to prioritize and manage workload to meet deadlines
Responsibilities
- 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.
- Accountable for meeting compliance standards including FDA, OSHA and Abbott policies and procedures.
Benefits
- Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
- Excellent retirement savings plan with a high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
