Senior Specialist Quality Assurance at Abbott

North Chicago, Illinois, United States

Abbott Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Diagnostics, Medical Devices, PharmaceuticalsIndustries

Requirements

  • Deep knowledge in Bioanalytical Quality Assurance methodologies
  • Strong foundational knowledge in broad range of bioanalytical techniques
  • Proven ability to guide and mentor laboratory teams
  • Proficient in laboratory investigations
  • Proven leadership, problem-solving, collaboration, time management, and communication abilities
  • Ability to balance multiple competing priorities
  • Skilled in managing specialized initiatives

Responsibilities

  • Implementing and maintaining the effectiveness of the Quality system
  • Providing daily oversight of laboratory testing operations, ensuring efficient workflow and adherence to quality standards
  • Identifying issues and implementing solutions to keep testing activities on track
  • Providing solutions to a wide range of difficult problems, ensuring solutions are compliant, innovative, thorough, practical, and consistent with organizational objectives
  • Leading projects with cross-functional or broader scope
  • Interacting effectively with employees, manager, and cross-functional peers, and representing own team on cross-functional project teams
  • Leading and executing design planning activities for alternate reagent and material identification, evaluation, and implementation to ensure continuity of testing operations
  • Collaborating cross-functionally to support product lifecycle management and ensure availability of critical testing materials
  • Communicating confidently and effectively with management, peers, and key stakeholders
  • Authoring and reviewing technical rationales, supporting investigations, and ensuring compliance with regulatory and quality standards
  • Leading smooth implementation and validation of new analytical technologies and test methods in the testing lab
  • Proactively identifying and implementing cost-saving opportunities
  • Driving continuous improvement and process optimization
  • Applying quality principles and performing complex analysis of quality records and reports to form recommendations for improvements
  • Making independent decisions within defined parameters, assuring compliance with site level policies, procedures, and quality systems
  • Ensuring compliant documentation in area of responsibility

Skills

Quality Assurance
Bioanalytical QA
Laboratory Testing
GMP
Regulatory Compliance
Problem-Solving
Project Management
Leadership
Workflow Optimization
Operational Excellence

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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