Food Safety Auditor

6 days ago

Chicago, United States Abbott Full time

Have you ever wanted to make a difference? 

At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.

Abbott Nutrition 

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, Glucerna and ZonePerfect – to help get the nutrients they need to live their healthiest life. 

MAIN PURPOSE OF ROLE

The Food Safety Auditor has the broad objective of reducing food safety risk in the manufacture and distribution of all products produced within the Abbott Nutrition third party manufacturing (TPM) portfolio.

You will require the ability to appropriately identify, assess and minimize risks within the TPM manufacturing network to assure the safety, efficacy, regulatory compliance and customer satisfaction.

In order to meet TPM QA business unit objectives, you will be responsible for assuring the appropriate departments are pulled in as needed to deliver on expected results.

As the leader for Global TPM Food Safety, you will need to provide creative risk mitigation strategies for new and existing projects / products to successfully deliver safe, quality foods in both infant and adult production.

Although you will work independently, you will need strong skills to lead cross-functional groups of SMEs and set expectations against key company and department goals while delivering results across a diverse global TPM network.


MAIN RESPONSIBILITIES

Ensures quality infrastructure and standards are in place and maintained at global TPMs to meet product compliance requirements.

Perform annual quality system and manufacturing process surveillance audits to applicable standards, regulations and company procedures / policies.

Prepare audit reports that establish the outcome of the audit and detail the non-conformances identified during the audit.

In collaboration with TPM Managers, track, and drive audit results, including corrective actions, and any required follow-up.

Support third party and regulatory agency inspections as needed.

Participate in relevant Division and AQR communities of practice with ownership change mgt of disseminated changes/strategies.

Establish appropriate service level agreements with key division functions.

Execute global food safety enhancement opportunities, food defence assessments, and improvement projects across US, EU and Asia TPM portfolios.

Support the qualification of new lines at TPMs

Support the identification and verification of Hazard analysis at TPMs in collaboration with division SMEs

Interpret and translate learnings from historical non-conformances and assess and prioritise residual risk across TPM portfolio

Conduct for-cause facility inspections at new and established TPMs as required.

QUALIFICATIONS

Bachelors Degree In Food Science/Chemistry, Chemistry, Biology, Microbiology, Engineering or other technical discipline or an equivalent combination of education and work experience

Experience/Background

Minimum 10 years -

Quality management experience in a GMP environment

The position requires a broad understanding of quality principles as well as the technical aspects of product / package / process, design, compliance, and manufacture across a wide range of product types.

Significant manufacturing and quality experience in all types of products, packages, and processes. Other relevant experience from R&D, Regulatory and Operations may be considered.

Experience managing in an environment with changing priorities and making appropriate risk-based decisions in the face of uncertainties. Proficiency in organizing and presenting complex technical information to upper level management.

Minimum 5 years

Experience in dealing with regulatory authorities such as FDA.

Managerial/leadership experience

Abbott is an equal opportunities employer.

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