Quality Assurance Specialist

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.

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 Inspections, Deviation Management, Annual Product Reviews, Vendor Management, Inspection Management, QMS/Quality Council Management, Risk Management.

Interprets customer needs, assesses requirements and identifies solutions to non-standard requests. Explains difficult issues and works to build alignment around a complex situation. Makes decisions within guidelines and policies which impact a range of standard and non-standard customer, operational, project or support activities.

Education Minimum Requirement

Bachelor’s degree*. Degree in Life Sciences, Science discipline, or Engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience. * In lieu of Bachelor’s degree as described above, equivalent direct experience of minimum 4 years of work experience in GMP Manufacturing or Laboratory environment or regulatory function.

Required Experience and Skills

• Minimum three (3) years in Pharmaceutical Quality, Quality Assurance, Quality Systems, Product Complaints, Pharmacovigilance, or related experience with progressive and demonstrated Quality decision-making responsibility
• Experience working in a regulated GMP environment required.
• Experience with complaint handling, adverse event processes, regulatory reporting, or quality investigations preferred
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment
• Demonstrated self-starter with capability to develop innovative solutions to challenges
• Deliver results across multiple functional areas at the site.
• Proven analytical aptitude, critical thinking skills, and ability to apply key concepts
• Speaks with courage and candor
• Effective and positive written and verbal communication skills
• In-depth working knowledge and application of GMPs