Quality Assurance Specialist

Quality Assurance Specialist

Description

• Build your future with Volt!
• 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.

• 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).

• Volt is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Volt is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact Volt.

• Volt does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with applicable laws.

• By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from VOLT and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help.