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Quality Manager Portfolio Expansion

hace 4 semanas

Mayagüez, Mayagüez, Puerto Rico Abbott Laboratories Company A tiempo completo
About Abbott Laboratories Company

Abbott Laboratories Company 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.

Our Mission

We're always looking towards the future, anticipating changes in medical science and technology. 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 get the nutrients they need to live their healthiest life.

What We Offer
  • Training and career development, with onboarding programs for new employees and tuition assistance
  • Financial security through competitive compensation, incentives and retirement plans
  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1
  • Vacation - 3 weeks accrued vacation (1st yr. is prorated) + vacation buy program + 3 personal days + 10 paid holidays
  • 401(k) retirement savings with a generous company match of 5%
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree
The Opportunity

This position works out of our Columbus, OH location in the Nutrition Division. This position is responsible for supporting the expansion of Abbott Nutrition (AN's) Third Party Manufacturer (TPM) portfolio through all stages of qualification. This requires collaboration with cross-functional personnel to lead and actively support activities through TPM selection, evaluation, approval, and first commercial run. The position also acts as the main AN Quality point of contact during the entire qualification process.

Responsibilities
  • Collaborating with TPM operations and process engineering groups in performing site assessments of potential TPMs
  • Conducting food safety and quality system audits of potential TPMs
  • Tracking and closing of corrective actions from audits
  • Identifying, elevating, and resolving food safety, food quality, compliance, and project risks associated with the qualification of a new TPM
  • Participating in the overall commercial project for launch of products at new TPMs
  • Managing the quality related project deliverables to meet the overall commercial project milestones and goals
  • Creating Standard Manufacturing Plans (SMPs) to provide documentation of specification and manufacturing details to the TPM
  • Coordinating with Global Supplier Quality to assure qualification of new ingredients and packaging
  • Negotiating initial Quality Agreements with new TPMs
  • Participating in product FMEAs by providing input on details of the TPMs quality system and processes
  • Aligning the TPM quality processes with AN quality expectations and quality systems
  • Releasing first commercial batches for distribution including assurance of proper investigation and corrective actions for any nonconformances or potential nonconformances
  • Transitioning new TPMs to the TPM QA group who supports business as usual activities
Requirements
  • Bachelor's Degree in Chemistry, Chemical Engineering, Biology, Bacteriology or other technical degree is required
  • Master's Degree preferred but not required
  • A minimum of seven years direct experience in a Quality Assurance, Supplier Quality Management, Compliance, or Quality Systems related position with application of and compliance to government regulations
  • Experience in a nutritional or allied industry is strongly preferred
  • Demonstrated leadership skills/competencies with a track record of success
  • Demonstrated experience successfully interacting and communicating with all organizational levels internally and externally (e.g. third-party manufacturers or external regulatory bodies)
  • Demonstrated ability to manage several activities / projects at once, organize / prioritize work