Quality Assurance Project Lead- Columbus, OH Plant

at  Abbott Laboratories

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 114,000 colleagues serve people in more than 160 countries.

ADDITIONAL LEAD JOB REQUIREMENTS:

• Point of contact for all Quality matters related to the project
• Member of the project Core Team
• Provides input in all phases of the project from the Front end planning through execution
• Ensures the appropriate Subject Matter Experts are involved in planning and decision making for the project
• Has oversight for all Quality Systems and ensures that all Quality System changes, equipment changes/additions, facility changes/additions/upgrade are in compliance with the standards established by Abbott, Abbott Nutrition and all other regulatory and certifying bodies
• Ensures the food safety/quality risks are properly identified and addressed
• Quality Engineers assigned to the project report to this role

ADDITIONAL PROJECT REQUIREMENTS:

• Responsible for monthly QA Pre-Steering review with QA senior management (site and Division)
• Responsible for quarterly update meetings with QA DVP (Fiona Mullins)
• Responsible for weekly updates with site QA director
• Project QA liaison to site Safeguard manager
• Responsible for coordinating Division QA support within the project (Supplier QA, Validation QA, Sterilization Tech, Sanitation, Design Assurance)

EDUCATION AND EXPERIENCE YOU’LL BRING

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• Core Project team leader providing Quality direction, consultation, decisions etc. during all project phases.
• Applies understanding of plant and facility operations with an extensive background in cGMP’s and Food Safety in a food and infant formula manufacturing environment.
• Ability to lead and execute complex and/or specialized projects. Support design and execution associated with additions/changes/upgrades to facility/equipment, processes, procedure and take necessary actions to sustain compliance with the changing business needs.
• Assures project execution complies with cGMP’s, FDA regulations and other practices outlined by federal statutes or other regulatory/certifying agencies. Provide regular, scheduled appraisals of site and/or project. Interacts with site and division senior leadership to provide updates and find solutions.
• Assure Food Safety hazard analysis, procedural changes, and other Food Safety related activities are conducted for all new and/or upgraded plant systems, equipment, or facilities.
• Assure new/upgraded/changed plant areas comply with Food Safety and cGMP’s as outlined by federal and other regulatory/certifying agencies.
• Provide design and front-end planning input to project teams related to sanitation and cGMPs for new/upgraded/changed plant areas/equipment/facilities.
• Perform cGMP audits and walk throughs of new/upgraded/changed plant areas/equipment/facilities with the purpose of monitoring project activities for compliance to cGMPs and proper sanitation practices. Assess the impact of new/upgraded/changed plant areas have across the Quality Systems of the plant and work with those area leaders to incorporate those changes into routine operations.
• Assess regulations on a routine basis to ensure the new/upgraded/changed or existing plant areas/equipment/facilities meet the requirements of our governing regulatory and certifying agencies and lead efforts in making those changes.
• Assess new Corporate and Division policies for potential impact on plant operations or Quality Systems under their responsibility and make recommendations for implementation.
• Review ECA’s, validation packages, preventive and routine maintenance work orders and other related documents specific to their area of responsibility including new plant areas or plant/equipment/facility upgrades and changes.
• Support RCA investigations and provide corrective/preventive actions and feedback where appropriate.
• The Site Quality Assurance Project Leader assures that all documents and operations in their area of responsibility, which will include new site projects, Quality System changes, regulatory changes, equipment changes/additions/upgrades, facility changes/additions/upgrade are in compliance with the standards established by Abbott, Abbott Nutrition and all other regulatory and certifying bodies. Failure to meet these commitments may result in major business interruptions due to food safety compliance, sanitation and/or cGMP impacts.
• The incumbent’s scope of authority encompasses providing recommendations for design/upgrade/changes which affect proper cGMP, sanitation, and documentation practices, setting standards regarding current cGMP’s and sanitation as well as developing additional site Quality System programs to ensure compliance for all quality related issues under their area of responsibility.
• This role is specific to leading new projects and initiatives at the site that encompass multiple quality systems. This can include but is not limited to major line/equipment or facility additions/changes and major regulation/policy changes.
• You’ll also be accountable for providing excellent customer service to the production teams and meeting our compliance standards including FDA, OSHA and Abbott policies and procedures.
• Develop Food Safety, Sanitation, and cGMP training programs for all employees and any additional training that may be related to new plant areas/equipment/facility changes/upgrades.
• Develop appropriate Food Safety and cGMP training programs in their area of responsibility and assist with training of employees as appropriate.
• Identify impact to Quality resources and develop resource plans to review with project, site and division leadership.