Document Control Specialist - Day Shift - Casa Grande, AZ

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

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.

• 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.

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