QA Compliance Specialist

Contract: Columbus, Ohio, US

Salary Range: 33.00 - 38.00 | Per Hour

Job Code: 360722

End Date: 2025-05-08

Days Left: 15 days, 22 hours left

To discuss more about this job opportunity, please reach out to Deepak Arya (LinkedIn URL - www.linkedin.com/in/deepak-arya-8a79aa22a/), email your updated resume at Email - deepak.arya@collabera.com or give me a call at (425)-298-1474. Thank you! 
 
Pay range: $33 to $38/hr.
 
Industry: Medical Device
 
Main Responsibilities
  • Responsible for management and execution of multiple mediums to large-scale projects that are organized into the Quality Intelligence Program Management Office (QIPMO) associated with regulatory requirements
  • Cross-functionally remediate current and future regulatory impact on the quality system
  • Ensure project scope is clearly defined: develop and manage project plans to meet deliverables
  • Manage cross-functional project timelines and follow up with project team members to ensure timely completion of tasks
  • Address any resource constraints associated through data driven business proposals to meet compliance requirements objectives and mitigate business risk
  • Responsible for identifying and managing critical project issues and risks, and timely communication to senior leadership
  • Provide clear and consistent communication, both oral and written to all project stakeholders on key project elements such as scope timeline, issues, etc
  • Understand and support AN Commercial QA and Quality Assurance Compliance organizations and opportunities for improvements
  • Integrate key AQR/AN QA initiatives as appropriate, based on compliance risk and availability of resources and business processes to support
  • Recommend and implement strategies and enhancements to improve efficiency
  • Develop and maintain effective KPIs that enable key success factors
  • Coordinate Quality Intelligence operations and business cycle updates.
  • The quality and compliance of AN products is a competitive advantage in the marketplace, and any lessening of our standards or not meeting market requirements can have an adverse long-
    term impact on our business. This position will work with limited supervision.
Education and experience you will bring:
Required
  • Preferably pediatric or medical nutrition products, in a Quality, R&D, Operations function and good knowledge/awareness of food cGxP and nutritional regulations, Pharma knowledge with 2 to 3 years of experience
  • Demonstrated ability in managing expectations on program requirements and deliverables
  • Demonstrated problem-solving abilities and knowledge in nutritional manufacturing controls and quality systems
  • Well-developed interpersonal, communication and negotiation skills.
  • Continuous improvement methods and application (for example: Lean, Six Sigma, Class A, etc.).
  • Cross-functional/cross-divisional stakeholder management experience
  • Applicable technical knowledge/experience
  • Sound decision-making skills contributing to high levels of competence, confidence and credibility
  • Experience dealing with international locations.

Preferred

  • Master’s degree
  • PMP certification
  • Ingredient expertise, process expertise, and formulation expertise in nutritional industry.
Job Requirement
  • Quality Assurance
  • Compliance
  • CAPA
  • FDA
  • Deviation
  • Audits
  • Documentation
  • Food Industry
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Deepak Arya
  • deepak.arya@collabera.com
Apply Now
Apply Now
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