Quality Professional IV

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 103,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

The Professional IV QA reviews Manufacturing documentation by obtaining all lot history records and non-conforming material reports and ensuring that they are compiled in accordance with internal procedures.

• Tracks Documentation discrepancies by maintaining a mechanism by which discrepancies with manufacturing documentation can be tracked to determine trends, etc.
• Notifies Manufacturing personnel of documentation issues by providing feedback immediately upon discovery of issues, and, on a periodic basis, informing manufacturing personnel in a more formal manner of discrepancies with manufacturing documentation.
• Confines discrepant materials by maintaining a Quarantine area whereby discrepant materials are physically located until they are resolved and can be released.
• Releases product by performing the necessary transactions in SAP in the sterile cycle to release product upon receipt of the Product Release Authorization and completion of LHR review.
• Reviews and approves Design History Files by obtaining and verifying the contents of DHFs and approving the Engineering Order authorizing release into the Archive department.
• Advises Manufacturing personnel and project leaders by functioning as the "expert" in the area of documentation compliance.
• Coordinates Clinical product by completing appropriate paperwork to release clinical product to approved sites.
• Audits materials or the work of others through the examination, inspection, measurement, or test of raw materials, components sub assemblies and documentation.

Accountability/Scope:

• Plans and organizes non-routine tasks w/approval.
• Initiates or maintains work schedule.
• Establishes priorities of work assignments.
• Solves a wide range of complex problems requiring advanced interpretation of generally defined procedures and practices.
• Selects methods and practices to obtain imaginative, thorough, and practical solutions to questions.
• Understands organizational structure and positions of key employees Maintains general knowledge of products/services associated with area and employees involved with specific product lines and services.

Minimum Qualifications:

• BS degree
• 5+ years of related work experience.

Preferred Qualifications:

• Experience applying solid knowledge of business concepts, procedures and practices, and a complete understanding fundamentals in a functional area, and working knowledge of other related disciplines.
• Experience performing in a quality system environment.
• Performs complex assignments usually without established procedures.
• Experience completing assignments with considerable judgment, initiative, creativity and leadership in troubleshooting, suggesting alternatives.
• Experience making recommendations for continuous quality improvement.

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