Quality Assurance Specialist
4 weeks ago
Grifols, a global healthcare company, is seeking a Quality Assurance Specialist to join our team in Huntsville, AL. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our plasma center operations.
About Grifols:Grifols is a leading global healthcare company that has been working to improve the health and well-being of people around the world since 1909. We are leaders in plasma-derived medicines and transfusion medicine, and we develop, produce, and market innovative medicines, solutions, and services in over 110 countries and regions.
Key Responsibilities:- Perform quality assurance and training functions to ensure compliance with internal and external regulations and protocols.
- Review and document equipment QC and maintenance records.
- Investigate and perform root-cause analysis for deviations and customer complaints related to product quality and/or donor safety.
- Inspect and release incoming supplies, investigating and reporting supplies that do not meet quality specifications and requirements prior to use.
- Perform documentation review for unsuitable test results.
- Assist the Quality Systems Manager to ensure compliance with cGMP regulation, SOPs, and regulatory requirements.
- Perform product release activities.
- Review lookback information and documentation.
- Review waste shipment documentation.
- Review unexpected plasmapheresis events, including electronic donor chart and related documentation.
- Review electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
- Review donor deferral notifications from competitor centers.
- Review plasma processing documentation to ensure proper freezing, storage, and handling of product.
- High school diploma or GED.
- No previous related experience required.
- Certification as a Donor Center Technician.
- Developing command of interpersonal communication, organizational, and problem-solving skills.
- Ability to understand FDA regulations.
- Strong integrity and commitment to quality and compliance.
- Good knowledge of mathematics.
- Legible handwriting.
- Proficiency with computers.
- Ability to work flexible scheduling to meet business needs.
- Ability to understand and follow SOPs and protocols.
- Competitive salary range: $55,000 - $65,000 per year, based on location and experience.
- Benefits package, including medical, dental, and vision insurance.
- 401(k) retirement plan with company match.
- Opportunities for professional growth and development.
- A dynamic and supportive work environment.
Huntsville, AL - USA
We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and detail-oriented individual who is passionate about quality and compliance, we encourage you to apply for this exciting opportunity.
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