Position Summary

The QA Associate supports the site's Quality Management System by managing product complaints, adverse events, and investigation activities. This role contributes to deviation and CAPA processes, audit support, and regulatory compliance efforts, while assisting with quality metrics, trend analysis, and continuous improvement initiatives

ESSENTIAL FUNCTIONS

Product Quality Complaints:

• Serve as the site point of contact for handling, managing, and performing product quality complaint investigations.
• Responsible for maintaining communication with patients and third parties to ensure all needs of the product quality complaint investigation are met and delivered to the respective party.

Adverse Events/ Pharmacovigilance

• Responsible for maintaining, managing, organizing, and ensuring adverse events and pharmacovigilant activities are appropriately addressed and triaged to the correct responsible party.
• Responsible for understanding and defending the methods and modes in which adverse events, product inquiries, and other pharmacovigilant activities are addressed.

Root Cause Investigations (Deviations and CAPAs)

• Serves as a subject matter expert for root cause investigation guidelines including
• Assists in ensuring investigations and CAPAs adhere to SMART principles and drive site wide continuous improvement activities.
• Responsible for developing, managing, and executing CAPA effectiveness checks, to ensure that the site is committed to improvement and to identify additional areas of improvement when applicable.

FAR

• Serves as a backup to facilitate the field alert reporting process as a process subject matter expert.
• Responsible for maintaining an accurate and informative log of field alerts and market actions for site trending and documentation.

Audit Scribing

• Serves as a point of contact to facilitate internal and external audits and communication with auditors.
• Specifically, serves as audit scribe to ensure that the audit activities are performed and executed in a controlled and efficient manner.

Trending Reports/ Metrics

• Responsible for completing annual trending reports for different corners of the quality management system, including deviations, CAPAs, and complaints.
• Trend reports will be developed with the year in review of data, to drive and address areas subject to continuous improvement.

Metrics

• Responsible for working with cross functional groups to acquire and maintain period data and metrics to deliver in clear, concise, and effective metric reports.
• Use entry level statistical analytical methods to determine effectiveness of systems and highlight areas for improvement.

Change Controls

• Serves as a back-up to the change control process as a change control coordinator.
• Assists with the management of the change control schedule and agenda, the review of and the approval of change controls. Serves as a subject matter expert to ensure site change controls adhere to proper regulatory requirements and site guidelines.

QUALIFICATIONS

Education & Experience

• Bachelor's degree in Pharmaceutical Sciences, Pharmacy or a related field.
• 1-3 years of experience in Quality Assurance within a pharmaceutical or regulated environment
• Familiarity with QMS platforms and electronic documentation systems preferred.

Knowledge & Skills

• Ability to communicate and work with teams
• Attention to detail
• Strong documentation skills

• Basic knowledge of GMP, deviations, CAPA, and change control processes
• Understanding of pharmacovigilance and product complaint handling preferred
• Ability to analyze data and support trending/metric reporting
• Proficiency in Microsoft Office (Excel, Word, PowerPoint)

• Ability to read and interpret SOPs and function within the scope of procedures
• Customer/Stakeholder focused (understands impact of daily work to compliance and overall business)
• Proof-reading skills; ability to identify errors
• Ability to read and comprehend documentation and requirements set forth in Batch Production Records (BPRs)
• Ability to work overtime as needed, including occasional weekend shifts

Physical Requirements

• Lift 15 lbs.
• Walk across plant/warehouse
• Wear appropriate gowning as required
• Ability to read for extended periods of time

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.