Volt is immediately hiring for Quality Assurance Specialist in Cedar Creek, Texas
As a Quality Assurance Specialist, you will: - Drives quality assurance activities related to batch review, change control, NCRs, Deviations, CAPAs, Audits, and supports Product Complaints technical investigations for the relevant product platforms.
- Support 3rd party audit of site through audit prep and participating in the front/back room.
- Apply advanced Quality Assurance and Scientific Method techniques and principles to daily tasks and activities.
- Apply relevant regulations, standards, GxP requirements, and industry best practices to assignments.
- Plan and conduct projects and activities with moderate to high technical responsibility, complexity, and strategic feedback.
- Act as an SME in quality assurance and scientific matters as applicable.
- Develop and drive key strategic quality assurance initiatives throughout the organization.
- Contributes to the development of new projects/programs/processes.
- Lead/drive root cause investigations for multiple issues, including complaints, NCRs, Deviations, OOS, etc.
- Leads projects requiring representation of the organization to internal and/or external customers or others, providing expertise and promoting solutions.
This is a full-time- contract opportunity.
The Ideal Candidate will have: - Bachelor's or master's Degree in biology, chemistry, biotechnology, engineering, or a related field, or equivalent experience.
- Post-graduate, Quality Assurance Certifications, such as Six Sigma, CQA, etc., is preferred.
- 4+ years of experience in a similar position within the Life science industry.
- Familiarity with medical device regulations, such as ISO 13485, FDA 21 CFR part 820, and IVDR 2017/746 is required.
- Strong organizational and analytical skills with a focus on finding effective and efficient solutions in compliance with the regulations.
PAY RANGE AND BENEFITS: Pay Range*: $50 - $52.10 per hour
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Qualified candidates should
APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
Benefits: Volt offers benefits (based on eligibility) that include the following: health, dental, vision, term life, short term disability, AD&D, 401(k), Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
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