Original listing text, shown exactly as published by the company.
WHAT YOU’LL DO
- Monitor the Exception Report (ER) / CAPA system to assure timely identification of root cause, and effective CAPA plans.
- Assist with, initiate, investigate, and/or plan correction activities, as required, when nonconformances are identified and lead or support the resolution and closure.
- Support and influence suppliers to drive to true root cause and implement effective corrective actions.
- Track and trend established QA metrics (KPI and CAPA). Communicate monthly and /or quarterly data, as required, to the Division and Corporate Levels.
- Identify new and / or modify and enhance existing sources of quality data for Continuous Improvement meetings.
- Facilitate Material Review Board (MRB) meetings to report status updates for open exception reports and allocate appropriate resources to meet target closure deadlines.
- Identify opportunities for improvements within CAPA system.
- Support and ensure technical readiness by the supplier in advance of new product launches, trials, etc.
- Maintain relevant documentation (ie. QA policies, procedures, specifications, and acceptance programs) and assure these documents are current and compliant to division and corporate level policies and procedures as well as external governing bodies.
- Assess gaps (where they exist) between plant and corporate and division level documents as well as in training profiles / curriculums and develop action plans to correct.
- Simplify, consolidate, and streamline procedures and forms used within the plant.
- Lead negotiations and execution of Quality Agreements and Standard Manufacturing Plans (SMPs) with suppliers, ensuring compliance with Abbott standards and regulatory
Accountability requirements. / Scope/Budget
- This position reports to the TPM Quality Manager for the Americas copacking and pediatric accessories, and is challenged to effectively provide direction, support, and leadership in ensuring the alignment of site level documents with division and corporate level policies and procedures and in working with the Compliance Manager to ensure compliance with Federal Regulations, International Standards/Directives, or other applicable governing bodies.
- In maintaining an effective Quality Management System and overseeing compliance to the overall operation, this position assists the Compliance Manager in providing oversight and ensuring that regulatory requirements are correctly interpreted and addressed.
- Failure to do so can result in regulatory vulnerability and regulatory action.
- In addition to the FDA or any other regulatory agency's impact, this position's actions when dealing with exception reporting, failure investigations, and the development of planned corrections and corrective actions can result in product recall or liability suits that may result in adverse publicity, branding and a reduction of sales on a long-term basis.
- Also, the inability to comply or to bridge a gap in the Quality System due to a compliance issue can greatly impact Abbott Nutrition (AN) division inventories and the ability to service customer demands.
EDUCATION AND EXPERIENCE
- Bachelor's degree, preferably in a science, engineering or life/physical sciences.
- Food industry a plus, but not required.
PREFERRED
- Preferred experience within a Global, multi-cultural organization.
- Preferred experience in Quality Assurance or supplier quality management: at least 5 years in a
QA Role / Compliance / Quality Systems or closely related position.
- Experience within a federally regulated industry is a plus, but not required.
- Thorough knowledge of manufacturing processes and quality assurance principles; with the ability to operate to internal and federal regulations.
- Results-driven with ability to successfully interact and communicate with all organizational levels internally and externally (e.g., suppliers or external regulatory bodies); demonstrated ability to manage several activities/projects at once with a strong sense of urgency, effectively prioritize work, and respond to time-sensitive business needs.
Apply Now
- Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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The base pay for this position is
$86,700.00 – $173,300.00In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:ANSC Nutrition Supply Chain
LOCATION:United States > Columbus : 2900 Easton Square Place
ADDITIONAL LOCATIONS
WORK SHIFT:Standard
TRAVEL:Yes, 20 % of the Time
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.…
