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Validation Project Coordinator (R&D) - Nutrition - Columbus, OH

Abbott
Columbus, Ohio, United States
Full-time

The Opportunity

Our location in Columbus, OH currently has an opportunity for a Validation Project Coordinator . In Research & Development, our ambition is providing innovative high-quality products, creating sustainable value, delivering superior user experience, and enhancing health outcomes at all stages of life.

Primary Job Function

Collaborate with Abbott Subject Matter Experts (SMEs) to ensure robust test method validation adhering to quality systems and supporting new product development (NPD).

Develop and share expertise on test method validation, supporting Abbott R&D (analytical and microbiological) on validation protocols and procedures.

Lead test method validation projects, aligning with strategic goals and optimizing resource use.

What You’ll Work On

Scope / Accountability :

  • Strategy : Develop and implement test method validation strategies with cross-functional teams, exercising discretion and independent judgment.
  • Quality of Work : Ensure accuracy, quality, and timeliness of documentation for test method validation projects, complying with all applicable quality standards and procedures.
  • Work Performance : Maintain positive work relationships, track and communicate milestone status, conduct periodic project reviews, and complete all assigned tasks within committed timelines while maintaining high-quality work.

Core Job Responsibilities :

  • Manage and prioritize laboratory test method validation change requests, providing status updates to stakeholders.
  • Serve as the SME for the area change request system (M-Files).
  • Initiate and manage change requests for new formulation method matrix assessments.
  • Collaborate on and update global method reference documents within the validation system (M-Files), ensuring compliance with internal policies.
  • Lead document change review meetings, ensuring follow-ups and closeout.
  • Share project updates with internal scientists and management through periodic reports.
  • Lead cross-functional meetings to achieve project objectives, mitigate risks, and resolve issues.
  • Develop and implement project management best practices and continuous improvement initiatives.

EDUCATION AND EXPERIENCE, YOU’LL BRING

Required :

BA / BS in chemistry or related scientific discipline and 3+ years of industry experience

Skills / Competencies :

  • Proficient in analytical and microbiological instrumentation and test methods.
  • Strong understanding of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
  • Proven ability to summarize project updates and escalate concerns.
  • Excellent time management and ability to prioritize multiple tasks with minimal supervision.
  • Skilled in scheduling, setting agendas, and leading cross-functional meetings.
  • Exceptional written and verbal communication skills.
  • Detail-oriented and results-driven to meet deadlines.
  • Effective communicator with diverse validation system users, providing guidance on navigation and processes.
  • Proficient in MS Word, Excel, and PowerPoint.
  • Familiar with revision tracking and document change control (preferred).
  • Strong leadership and team management skills, driving continuous improvement and best practices in project management.

Preferred :

  • Project management skills
  • Knowledge of documentation change control (M-Files a plus) and validation process

MISC

  • This is an onsite role.
  • There is no relocation offered for this role.
  • 12 days ago
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