Quality Assurance Specialist

Regulatory Toolkit; Pennsylvania; On-site; USD 70,000 - 95,000; Full time

Job summary

Regulatory Toolkit is seeking a Quality Assurance Specialist (P2) to support health authority reporting, adverse event management, and complaint sample coordination. You will serve as a liaison among QA, pharmacovigilance, manufacturing, and regulatory affairs to ensure timely evaluation and compliant reporting of product quality issues.

The role emphasizes adherence to GMP and global regulatory requirements, with responsibilities spanning sample handling, investigation support, and

Responsibilities

• Author Adverse Event Quality Investigation Reports
• Coordinate receipt, tracking, storage, shipment, testing, and disposition of complaint samples
• Maintain complaint sample inventory and chain-of-custody records
• Work with laboratories and investigation teams to ensure complaint samples are tested within established timelines
• Ensure complaint samples are handled and retained according to GMP and company requirements
• Support sample reconciliation activities and maintain accurate documentation
• Author Health Authority responses and notifications
• Review and update procedures, work instructions, and training materials related to complaint handling and reporting processes
• Maintains expert level of knowledge relating to core internal procedures and applicable regulations (domestic and international)
• Participates on teams supporting internal functions and/or evaluating site processes for improvement opportunities
• Provides information for regulatory inspections as requested
• Completes special projects or assignments as directed by management including conducting education and training on GMP requirements
• Individual may have the opportunity to support other areas within the West Point Quality Assurance organization, including: SOP and Batch Record Management, Audits and Ins

Job description

Job Description

Are you looking for an exciting opportunity with a rapidly growing pharmaceutical manufacturer? If so, then this is the opportunity for you!

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Quality Assurance Specialist (P2) is responsible for supporting Quality Systems processes related to Health Authority reporting, product complaint intake and assessment, adverse event management, and complaint sample coordination. This role ensures compliance with global regulatory requirements, internal quality standards, and company procedures for the timely evaluation, documentation, investigation, and reporting of product quality complaints and adverse events.

The successful candidate will serve as a key liaison between Quality Assurance, Pharmacovigilance, Manufacturing, Regulatory Affairs, and external stakeholders to ensure accurate complaint processing, effective sample management, and regulatory reporting activities.

In addition, responsible for carrying out divisional requirements as necessary. Work is primarily achieved by individual or through project teams. Understands and applies regulatory/compliance requirements relative to their role. Has developed conceptual and practical expertise in own discipline. Applies knowledge of internal/external processes to drive improvements. Solves complex problems; takes a new perspective using existing solutions. Works independently, receives minimal guidance.

Primary Responsibilities

• Author Adverse Event Quality Investigation Reports
• Coordinate receipt, tracking, storage, shipment, testing, and disposition of complaint samples.
• Maintain complaint sample inventory and chain-of-custody records.
• Work with laboratories and investigation teams to ensure complaint samples are tested within established timelines.
• Ensure complaint samples are handled and retained according to GMP and company requirements.
• Support sample reconciliation activities and maintain accurate documentation.
• Author Health Authority responses and notifications

• Review and update procedures, work instructions, and training materials related to complaint handling and reporting processes.
• Maintains expert level of knowledge relating to core internal procedures and applicable regulations (domestic and international). Reviews regulatory citations and other pertinent information
• Participates on teams supporting internal functions and/or evaluating site processes for improvement opportunities
• Provides information for regulatory inspections as requested
• Completes special projects or assignments as directed by management including conducting education and training on GMP requirements
• Individual may have the opportunity to support other areas within the West Point Quality Assurance organization, including:
  • SOP and Batch Record Management
  • Audits and Ins