QA Associate (QMS)
The QA Associate at Confidential Client supports the Quality Management System by managing product complaints, adverse events, and investigation activities. This role is responsible for deviation and CAPA processes, audit facilitation, regulatory compliance, and driving continuous improvement through quality metrics and trend analysis. The position requires collaboration across teams to ensure compliance and effective quality assurance in a pharmaceutical environment.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, IT.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
Role overview
Confidential Client is hiring a QA Associate (QMS) to support the site Quality Management System. This full-time role will manage product complaints, triage adverse events, contribute to investigations (deviations & CAPAs), support audits (including audit scribing), and produce trending/metric reports that drive continuous improvement.
What you’ll do
- Serve as the primary site contact for product quality complaint handling and investigations.
- Communicate with patients, vendors, and third parties to collect information and close complaints.
- Manage adverse event/pharmacovigilance triage and ensure issues are routed to the proper owner.
- Support root-cause investigations for deviations and CAPAs; help ensure corrective actions follow SMART principles.
- Develop, execute, and document CAPA effectiveness checks and follow-up activities.
- Act as a backup for Field Alert Reporting (FAR) and maintain accurate logs for market actions and trending.
- Serve as audit scribe and point of contact during internal and external audits.
- Prepare annual trending reports and periodic metric reports (deviations, CAPAs, complaints).
- Use entry-level statistical analysis to evaluate system effectiveness and identify improvement opportunities.
- Support change control coordination and help manage the change control schedule and approvals.
- Work cross-functionally to collect metric data, maintain documentation, and support continuous improvement efforts.
Qualifications
- Bachelor’s degree in Pharmaceutical Sciences, Pharmacy, or related field.
- 1–3 years’ experience in Quality Assurance within a pharmaceutical or other regulated environment.
- Familiarity with QMS platforms and electronic documentation systems preferred.
- Basic knowledge of GMP, deviations, CAPA, change control, and complaint management.
- Understanding of pharmacovigilance and adverse event handling is a plus.
Core skills
- Strong written documentation and proofreading skills.
- Attention to detail and the ability to follow SOPs and BPR requirements.
- Effective verbal communication and cross-functional collaboration.
- Proficiency in Microsoft Office (Excel, Word, PowerPoint).
- Ability to analyze data for trending and metric reporting.
- Customer/stakeholder focus and an orientation toward compliance and quality.
- Willingness to work overtime as needed, including occasional weekends.
Physical & workplace requirements
- Ability to lift up to 15 lbs.
- Ability to walk across plant/warehouse areas and wear required gowning.
- Ability to read and review documentation for extended periods.
Compensation
- Estimated pay: $50,832 per year (as listed in the source posting). Actual pay may vary based on experience and internal policies.
Additional notes
- This position is full-time.
- Confidential Client and Careertakes comply with applicable US employment laws. Reasonable accommodations are available for qualified applicants with disabilities; please inform the hiring team during the process if you require accommodations.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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