GMP Auditing for Quality Assurance Training Course

This training course is designed for professionals in the pharmaceutical industry to learn effective GMP auditing and quality assurance strategies. The course covers topics such as GMP regulatory frameworks, types of audits, and corrective actions. The training is pre-approved by RAPS and is suitable for QA/QC professionals, regulatory compliance managers, and manufacturing supervisors. The course aims to provide participants with the knowledge and skills needed to conduct competent audits and ensure compliance with pharmaceutical regulations.

Grifols, a global healthcare company with a strong presence in the United States, is currently seeking a Quality Systems Manager (QSM) for its plasma donor center in Worcester, Massachusetts. The role is critical in ensuring the quality and safety of plasma-derived medicines and transfusion medicine, which Grifols produces and markets in over 110 countries and regions.

The primary responsibilities of the Quality Systems Manager include evaluating processes, developing action plans, and coordinating the strategic implementation of quality system processes and corrective actions at the plasma donor center. They are also responsible for maintaining oversight of the center’s quality management system, ensuring continuous quality improvement, and addressing deficiencies in a timely manner. Additionally, the QSM will direct and monitor processes to ensure center compliance with all applicable state, federal, and company-designated regulations, and implement Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance.

The role requires a Bachelor of Science degree or equivalent, along with 2 years of related experience in a medical and/or cGMP regulated environment. Experience with plasma or whole blood is preferred. Key skills include command of interpersonal communication, organizational and problem-solving abilities, understanding and assessing FDA regulations, strong integrity, and commitment to quality and compliance.

Grifols offers a comprehensive benefits package, including medical, PTO, up to 5% 401K match, and tuition reimbursement. The company is committed to providing opportunities for professional growth and career progression, and it values a family-like culture despite its global presence.

The role is located in Worcester, Massachusetts, with potential travel within the United States for meetings, events, and occasional support of other centers. The work environment includes exposure to biological fluids, infectious organisms, and other potential hazards, requiring the use of personal protective equipment.

[1] https://www.linkedin.com/jobs/view/quality-systems-manager-at-grifols-4268821111