Sr QA Specialist - Contract - Dallas TX
Are you passionate about quality and precision? Join our client in this Sr QA Specialist position and help ensure top-tier standards every day.
Proclinical is seeking a Sr QA Specialist to provide quality assurance oversight in a regulated environment.
Primary Responsibilities:
This role involves ensuring compliance with current Good Manufacturing Practices (cGMPs) across various operational areas, including distribution processes, batch disposition, and new product introductions. You will play a key role in managing quality investigations, deviations, and CAPAs while driving continuous improvement initiatives.
Skills & Requirements:
- Bachelor's degree in a relevant field.
- Experience in quality assurance within a regulated environment or related industry.
- Strong knowledge of GXP regulations and auditing techniques.
- Proficiency in applicable computer software.
- Excellent organizational, communication, and writing skills.
- Ability to manage multiple tasks effectively.
- Familiarity with risk management, change control, and CAPA processes.
- Physical ability to perform job functions, including occasional lifting (up to 25 pounds) and exposure to warehouse environments.
- Willingness to travel occasionally (less than 10%).
The Sr QA Specialist's responsibilities will be:
- Serve as the primary subject matter expert for TrackWise in operations investigations, deviations, and CAPAs.
- Lead comprehensive quality investigations, including root cause analysis for deviations, complaints, and distribution events.
- Act as the quality point of contact for distribution complaints and issue resolution involving CMOs and logistics providers.
- Oversee the quality release process for finished product distribution, including visual inspections for market readiness.
- Manage temperature monitoring programs for cold storage and shipment of finished products.
- Collaborate with manufacturing sites to address quality issues such as consumer complaints and product storage conditions.
- Review and approve artwork and rework instructions to ensure compliance with cGMP requirements.
- Participate in project teams to support new product introductions and changes to existing products, ensuring adherence to quality systems.
- Contribute to inspection readiness activities and regulatory agency inspections.
- Provide guidance on remediation activities and escalate critical issues as needed.
- Identify opportunities for improvement and lead or support process improvement initiatives.
- Act as a backup for other QA personnel as required.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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