Quality Assurance Associate

Vista, CA

Employer:	Grifols Plasma (Biomay USA)
Category:	QA - Quality Control
Job Type:	Full Time
Description
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Summary : Highly detail oriented, reliable, and motivated individual to perform a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements and corporate quality policies. Primary Responsibilities : Support QA management to ensure product quality and compliance with cGMPs . Assist with release of documentation related to the receiving, storing, manufacturing, and shipping of product. Interface with Sales, Administrative and Manufacturing departments to ensure documentation compliance with customer specifications and applicable regulatory requirements. Support Operations and Quality departments with issues of compliance to established company policies, regulatory guidance or client specific requirements. Support QA management in periodic internal audits as well as audits of contract testing laboratories, suppliers and other contract service providers as needed. Assist with CAPAs, complaints and NCMRs as needed. Ensure all personnel are adequately trained in Quality, Safety, ISO, OSHA, cGMP, and applicable CFRs. Perform final batch record review and release. Effectively communicate quality policy and objectives within the Quality department. Perform additional duties as assigned. Liaison with external parties on matter relating to QMS. Knowledge, Skills, and Abilities : Familiar with ISO 9001, FDA QSR requirements Exceptional written and verbal skills Ability to multitask with excellent attention to detail Ability to organize, plan and execute assignments with minimal supervision Ability to perform detailed record reviews for extended periods of time on a daily basis Education and Experience : High school graduate or GED required Typically requires 2 years of related experience. Pay Scale: The estimated pay scale for the Quality Assurance Associate role based in California, is $26.49 - 39.74 per hour. Additionally, the position is eligible to participate in the company 5% bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, 9 paid Holidays per year, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us! Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with arrests or conviction records, in a manner consistent with the requirements of applicable state and local laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and City of Los Angeles' Fair Chance Initiative for Hiring Ordinance. Learn more about Grifols (https://www.grifols.com/en/what-we-do) Req ID: 523197 Type: Regular Full-Time Job Category: Quality

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Quality Assurance Associate

Vista, CA

Description