CAPA Specialist, Microbiology - Sturgis, MI Plant at Abbott

Sturgis, Michigan, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Nutrition, PharmaceuticalsIndustries

Requirements

Ability to progress investigations through the CAPA system
Skill in working closely with other functional areas using investigational tools to determine root cause of nonconformities
Capability to ensure CAPA plans address root causes and that corrective and preventative actions are implemented effectively
Proficiency in evaluating and progressing timely completion of CAPA system activities, including effectiveness checks for non-conformances, potential non-conformances, and deviations
Experience facilitating investigation processes to identify appropriate root/potential causes and implement effective actions
Knowledge to maintain CAPA system records for audit-readiness (internal and external)
Ability to manage CAPA-related documentation in a complete, clear, concise, and controlled manner
Demonstrated ability to support a cross-functional team environment compliant with Corporate and regulatory requirements
Effective communication, interpersonal interactions, and business behaviors consistent with the Abbott Code of Conduct

Responsibilities

Progress investigations through the CAPA system
Collaborate with other functional areas using investigational tools to determine root cause of nonconformities
Ensure CAPA plans address root causes and corrective/preventative actions are implemented for rapid, compliant product/process/system improvements
Ensure actions are on time, thorough, complete, meet business/customer needs, and comply with standards/procedural requirements
Serve as an effective member of multifunctional teams
Evaluate and progress timely completion of CAPA activities from the Quality System
Facilitate investigation processes to ensure appropriate root/potential causes and effective actions to reduce nonconformance occurrence/recurrence
Maintain effectiveness of CAPA system records for audit-readiness
Manage all CAPA-related documentation completely, clearly, concisely, and in a controlled manner
Support a work environment ensuring team effectiveness and compliance with Corporate/regulatory requirements
Support other organizations in managing their CAPA actions, ensuring investigations are initiated and completed completely, concisely, and timely

Skills

CAPA

Microbiology

Quality Assurance

GMP

Root Cause Analysis

Regulatory Compliance

Laboratory Testing

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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