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, NutritionIndustries

Requirements

Knowledge of CAPA systems and investigational tools to determine root causes of nonconformities
Ability to evaluate and progress timely completion of CAPA activities, including effectiveness checks for non-conformances, potential non-conformances, and deviations
Skill in facilitating investigation processes to identify appropriate root/potential causes and implement effective corrective and preventative actions
Capability to maintain CAPA system records for audit-readiness (internal and external quality system audits)
Proficiency in managing CAPA-related documentation in a complete, clear, concise, and controlled manner
Experience working effectively in multifunctional teams, ensuring compliance with Abbott Code of Conduct, Corporate, and regulatory requirements
Ability to support other organizations in managing CAPA actions, ensuring investigations are complete, concise, and timely

Responsibilities

Progress investigations through the CAPA system
Collaborate with functional areas using investigational tools to determine root causes of nonconformities
Ensure CAPA plans address root causes and that corrective/preventative actions are implemented for rapid, compliant product/process/system improvements
Verify that CAPA actions are on time, thorough, complete, meet business/customer needs, and comply with standards/procedural requirements
Evaluate and progress timely completion of CAPA system activities raised from non-conformances, potential non-conformances, and/or deviations
Facilitate investigation processes to implement effective actions reducing occurrence/recurrence of nonconformances
Maintain effectiveness of CAPA system records for audit-readiness
Ensure all CAPA-related documentation is managed completely, clearly, concisely, and in a controlled manner
Support a work environment ensuring team effectiveness and cross-functional compliance with Corporate/regulatory requirements
Support other organizations in managing CAPA actions to ensure investigations are initiated and completed completely, concisely, and timely

Skills

CAPA

Microbiology

Quality Assurance

GMP

Root Cause Analysis

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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