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Research Associate Ii, Product Quality

2+ years
Not Disclosed
10 Sept. 23, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

This is Where You Save and Sustain Lives

At Baxter, our mission deeply connects us. Every role contributes to a positive impact on people worldwide, fostering a sense of purpose as we improve outcomes for millions of patients.

Our products and therapies are present in nearly every hospital globally, in clinics, and at home. With over 85 years of pioneering significant medical innovations, we are transforming healthcare.

Together, we cultivate an environment where success, happiness, and inspiration thrive. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose drives our mission forward.

Responsibilities

Your key responsibilities will include, but are not limited to:

  • Document Review: Review and approve technical documents for the Global Product Research and Development (GPRD), including analytical and formulation documents.
  • Compliance Investigations: Conduct tool-based investigations at CMO, R&D, plant, and contract laboratories to ensure adherence to cGxP regulations and guidelines.
  • Quality Management System (QMS): Review and approve QMS documents such as change controls, investigations, and audit reports using TrackWise.
  • Market Complaints: Handle market complaints and manage the quality management system, including change controls, CAPA, deviations, and Out of Specification (OOS) reports.
  • Audit Coordination: Coordinate with internal and external auditors to ensure timely closure of audit findings.
  • Regulatory Guidance: Provide expert advice on cGxP regulations and guidelines.
  • SOP Management: Prepare, review, and implement Standard Operating Procedures (SOPs).
  • Internal Audits: Conduct internal quality audits of the R&D laboratory, ensuring compliance with Good Laboratory Practices (GLP).
  • Risk Assessment: Review and approve risk assessments related to commercial product support, including human factor studies, accelerated aging studies, pFMEA, and sterilization assurance.
  • Performance Monitoring: Monitor and evaluate the performance of processes and analytical methods to identify issues or deviations.
  • Cross-Department Collaboration: Work with other departments to ensure all methods and procedures comply with compendial standards.
  • Subject Matter Expertise: Represent quality expertise in process and analytical validation, verification, and transfer both internally and externally.
  • Compliance Verification: Conduct GEMBA walks to verify compliance.
  • Supplier Notifications: Manage Supplier Notifications of Change (SNCs).

Reasonable Accommodations

Baxter is committed to providing reasonable accommodations for individuals with disabilities. If you need assistance during the application or interview process due to a medical condition or disability, please click here to inform us of your needs along with your contact information.

Recruitment Fraud Notice

Baxter has identified instances of employment scams where fraudulent parties impersonate Baxter employees or recruiters to obtain personal or financial information. To protect yourself, please review our Recruitment Fraud Notice.