Grifols Shared Services North America, Inc Quality Assurance Supervisor in Clayton, North Carolina
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
The QA Supervisor coordinates and supervises the inspection and release of plasma lots for sale or further manufacture. Verifies critical systems at Grifols Plasma Logistics East, and documentation associated with the destruction of plasma. Ensures compliance to approved procedures. This position has responsibility for the quality acceptance and release of plasma product shipments and supervision of the daily activities of Grifols Plasma Logistics East,) quality assurance staff.
Supervises the daily activities of the Grifols Plasma Logistics East,quality assurance staff and ensures that required activities related to the receipt, storage, clearing, processing of Lookback Alerts, quarantine of unsuitable units, and release of Source Plasma for further manufacture or sales.
Responsible for the QA release of plasma from Grifols Plasma Logistics East, and verifies that all shipment contents meet standard operating procedures, regulatory and customer requirements prior to release.
Reviews and verifies temperature documentation to ensure conformance to appropriate temperature specifications.
Investigates and documents deviations noted as a result of routine compliance reviews, internal and external audits and customer complaints.
Participates in the writing and revision of policies and procedures related to Source Plasma at the Grifols Plasma Logistics East,facility.
Monitors Plasma Operations in order to maintain compliance with all applicable regulations, cGMPs and CFRs. Participates in internal audit for the Grifols Plasma Logistics East, facility. Interfaces with multiple levels of management and various support and service groups internally and externally.
Trains current and new employees, maintains and updates training records of the QA staff. Supervises the activities of quality assurance staff including hiring, performance management, disciplinary action and professional development.
Meet quality assurance and company financial objectives by monitoring department costs.
Education and Experience
Bachelor degree in life sciences or related field ideal.
Strong analytical, organizational and interpersonal skills with extensive knowledge of cGMPs as specified in the CFR/USP and EP Pharmacopeia / ICH and ISO Guidelines. Excellent written/verbal/leadership skills must be able to make sound decisions that may affect the quality purity or efficacy or a drug product. Anticipates and identifies problems; analyzes situations; consider alternatives; monitor and evaluates results in a systematic manner.
Typically requires a minimum of 5 years of Quality Assurance related experience and 3 years working in pharmaceuticals. Project or technical leadership experience required. Supervisory or management experience preferred.
Ability to read and review documents for up to four (4) hours at a time. Ability to stand for extended periods of time - up to four (4) hours at a time. Ability to lift, tug, pull up to fifty (50) pounds. Ability to travel via automobile and/or airplane.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 78225
Type: Regular Full-Time
Job Category: Quality