Senior Quality Assurance Specialist

3 weeks ago


Charlotte, North Carolina, United States Octapharma Plasma, Inc. Full time

About the Job

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We are seeking a skilled Senior Quality Assurance Specialist to join our team at Octapharma Plasma, Inc. in Charlotte, North Carolina.

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This is an exciting opportunity to work with a leading plasma collection company that specializes in creating life-saving medicines for patients worldwide.

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About the Role

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The successful candidate will be responsible for developing and maintaining equipment validation policy and adhering to regulatory requirements.

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You will perform the development and execution of process validation protocols and documents consistent with FDA and EU guidelines.

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Your main goal will be to ensure regulatory requirements are met during the development of equipment validation protocols.

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About You

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We are looking for a highly experienced professional with a Bachelor's degree in IT, life science or related field.

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You should have at least three years' experience in the biologics, drug manufacturing, or medical device industry or FDA regulated laboratory.

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A minimum of two (2) years of validation experience in a regulated industry is required.

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You should also have demonstrated knowledge of cGMPs, FDA regulations, SOP implementation, and validation principles and compliance standards.

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What We Offer

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We offer a competitive salary range of $75,000 - $90,000 per year, depending on your level of experience.

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You will receive formal training, outstanding plans for medical, dental, and vision insurance, health savings account (HSA), employee assistance program (EAP), wellness program, 401(k) retirement plan, paid time off, and company-paid holidays.

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About Us

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Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide.

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We are growing at an impressive pace, and so is the positive impact of our work.

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Join Our Team



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