Quality Systems Associate

Overview Would you like to join an international team working to improve the future of healthcare? 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. Quality Systems Associate Summary Under the direct supervision of the Quality Systems Manager, perform quality assurance and Training functions to ensure compliance with internal and external regulations and protocol. Responsibilities Completes weekly review of equipment QC and maintenance records. Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they related to product quality and/or donor safety. Inspects and releases incoming supplies. Investigates and reports supplies have not met quality specifications and requirements prior to use. Performs documentation review for unsuitable test results. Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed. Duties include: Under the direct supervision of the Quality Systems Manager, perform quality assurance and Training functions to ensure compliance with internal and external regulations and protocol. Performs all product release activities. Reviews lookback information and documentation. Reviews waste shipment documentation. Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process. Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality. Reviews donor deferral notifications from competitor centers. Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product. Quality Systems Associate – Assist the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents. Duties include: Creates, maintains, and audits training records and files to ensure compliance. Performs employee training observations to ensure staff competency prior to releasing employees to work independently. Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations. On an occasional basis, when the Quality Systems Manager is absent, the Quality Systems Associate may be required to perform the following duties: Reviews and approves of deferred donor reinstatement activities. Assists with completion of the internal donor center audit. Additional Responsibilities Is certified and maintains certification as a Donor Center Technician. Knowledge, Skills, and Abilities 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. Performs basic document review and employee observations. Communicates openly with the CQM on issues noted during reviews. Ability to understand and follow SOP’s and protocols. Ability to perform primary responsibilities of the Quality Associate role in a proficient manner. Has a basic understanding of cGMP and quality systems. Is able to spend hours sitting and reviewing documentation for accuracy. Demonstrates good organizational skills and attention to detail. Education High school diploma or GED. Obtains state licensures or certifications if applicable. Experience Typically requires no previous related experience. Occupational Demands Work is performed in a plasma center with exposure to biological fluids and potentially infectious organisms. Exposures to electrical equipment, extreme cold, and use of PPE are required. Job involves prolonged sitting and standing, bending, twisting, frequent hand and finger movements, and occasional lifting (up to 50 lbs). Vision and hearing requirements are specified; ability to communicate effectively and work independently is needed. #biomatusa Compensation and Benefits The estimated pay scale for the Quality Systems Associate role based in Van Nuys, CA is $24.48-33.12 per hour. The position is eligible to participate in up to 5% of the company bonus pool. Benefits include Medical, Dental, Vision, life insurance, PTO, paid holidays, up to 5% 401(K) match and tuition reimbursement. Final compensation depends on education, experience, skillset, and market data. Equal Employment Opportunity Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices and observances, national origin, pregnancy, childbirth, or related medical conditions, status as a protected veteran or spouse/family member of a protected veteran, or disability. We will consider qualified applicants in a manner consistent with applicable laws. #J-18808-Ljbffr