Senior Quality Professional Validation at Abbott

Des Plaines, Illinois, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

Bachelor’s degree in a related field
Minimum of 3 years of industry experience, preferably within pharmaceutical or related industries
Strong understanding of various quality and operational systems supporting facility, equipment, utilities, and computer systems
Solid working knowledge of cGMP regulations

Responsibilities

Ensuring compliance with applicable Corporate and Divisional policies and procedures
Managing all validation activities, including protocol development, document review, controlled document storage, and resolution of problem reports
Supporting CAPA activities within the Global Engineering Services (GES) organization
Contributing to GES compliance and validation programs by maintaining records, preparing metrics, and tracking action items
Assisting with internal, Corporate, Divisional, Regulatory, and third-party audits related to GES
Writing, reviewing, approving and/or executing documentation for new and current validation procedures and technical reports related to qualified facilities/utilities/equipment, validated spreadsheets, validated systems, and/or validated processes
Representing division, department, and group interests as a QA Validation Representative in meetings, conference calls, or as needed
Ensuring compliance with division, corporate, and regulatory requirements by providing quality guidance to customers and clients on policies and procedures related to development and validation
Providing support to ensure that Departmental Validation Master Plans are developed, approved in a timely manner, and adhered to
Investigating/troubleshooting validation problems for qualified facilities/utilities/equipment, validated spreadsheets, validated systems, and/or validated processes
Serving as an Abbott Engineering Standards (AES) committee member
Developing and evaluating quality process and system standards to ensure compliance with company standards and regulatory requirements
Assisting with establishing and updating corporate validation policies
Conducting External Supplier Evaluations and managing the Approved Supplier List

Skills

Validation

Quality Assurance

Compliance

Molecular Diagnostics

GMP

FDA Regulations

Quality Management

Risk Assessment

Audit Management

CAPA

SOP Development

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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