Job Description
At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a QA Deviation Specialist.
Position Type:
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to XXXXXXX at XXX-XXX-XXXX to learn more.
#LI-VK1
#HbM6349
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a QA Deviation Specialist.
Position Type:
- Contract
- On-Site
- Bachelor's degree from an accredited college or university.
- 10+ years of experience working in Aseptic Processing facilities, with demonstrated expertise in manufacturing deviation investigations and technical report writing.
- Expert-level understanding of deviation management, manufacturing process investigations, Root Cause Analysis, and CAPA development and execution.
- Previous experience supporting or executing remediation plans in response to US FDA observations or regulatory requirements.
- Extensive Quality Assurance experience across multiple areas, including PQR, auditing, change control, complaints management, OOS investigations, batch record review, and documentation management.
- Experience with training programs, supplier quality management, and broader pharmaceutical quality systems within regulated manufacturing environments.
- Excellent written and verbal communication skills in English and other relevant languages, with strong collaboration, conflict resolution, and problem-solving abilities, and a demonstrated focus on KPIs and project goals.
- Lead Minor, Major, and Critical Deviation investigations within assigned areas, ensuring thorough documentation and compliance with established quality procedures.
- Collect, review, and analyze relevant raw data, records, and supporting information to facilitate comprehensive investigations.
- Lead Root Cause Analysis (RCA) activities to identify probable root causes, assess potential product impact, and establish appropriate CAPAs with assigned owners and due dates.
- Perform deviation trending and data analysis to identify adverse trends, recurring issues, and opportunities for corrective action.
- Prepare, review, and finalize comprehensive investigation reports, ensuring accuracy, quality, and completion within established timelines.
- Develop and implement effective Corrective and Preventive Actions (CAPAs), including follow-up mechanisms to verify implementation and long-term effectiveness.
- Manage client communications, provide regular project progress updates, and report performance metrics to Project Leadership while ensuring timely approval and closure of investigation reports.
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to XXXXXXX at XXX-XXX-XXXX to learn more.
#LI-VK1
#HbM6349
Numbers & Facts
| Location | Round Lake, IL |
| Industry | Staffing/Employment Agencies |
| Salary | $73–$78.56 Per Hour |
| Company Size | 100 to 499 employees |
| Website | http://www.hiredbymatrix.com |
About Company
We believe in putting people together for the right reasons. Getting you a great job that makes you feel fulfilled in your career. Finding the perfect candidate to help you achieve business success.
Whether you are looking for the best candidate for your company or searching for your next career move, we are dedicated to making sure you thrive. We take your needs personally and have a variety of services to ensure you reach your goals. We listen to the needs of our clients and candidates and then thoughtfully match the right person with the right job. When people come together doing what they love success is guaranteed and partnerships last.
Skills
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