Full Description

Essential Job Responsibilities and Duties • Facilitating and evaluating center and equipment readiness • Responsible for all quality personnel functions including hiring, assignment and direction of work, development and training, disciplinary actions and termination, and the maintenance of all quality personnel records • Oversee daily actions that facilitate product collection (sample collection and submission; testing results, staging) • Assist the Quality Assurance Unit (QAU) ensuring donor center records are complete and accurate • Ensure shipments (sample, product, waste, etc.) are managed and labeled accurately • The interpretation and application of SOPs; and, ensuring SOP revisions are implemented correctly, efficiently and effectively • The receipt, approval and release of donor center supplies. • Assist Center Management and Training Coordinator to ensure training is conducted and documented as directed, review and prepare for inspections/audits, and to develop CAPA, and other quality duties as assigned • Oversee and manage the center’s Deviation Management System to ensure adequate investigations are completed, accurate root cause(s) identified, and CAPA process is identified and managed • Track and trend the center’s quality and operational metrics with respect to applicable SOPs. • Perform periodic self-assessments of the center’s quality and compliance • Administratively oversee the performance and submission of the center’s Proficiency Testing process (Note: this does not replace any CLIA regulated process) • Manage the document control process of the center and suggest necessary SOP changes as required • Supervise the center’s Quality Assurance Unit employees • Work effectively and partner with the Field Quality, Operations support, Center Director and Corporate staff to ensure daily operations are in full compliance • Maintain an open line of communication with Management • Responsible for working through multiple projects and managing multiple competing priorities. • Other duties as assigned Qualifications • Bachelor’s Degree in a scientific discipline, life sciences or related discipline preferred or (12) twelve months experience related to quality, regulatory or related industry provided that the experience was obtained in a regulated environment. • Necessary education/experience may be substituted for the position with approval from the Director of Quality Assurance or VP of Quality Assurance. Requirements • Must be fully signed off and capable of performing duties of the Manager of Quality Assurance • Demonstrate expertise in interpreting cGMPs, FDA regulations, SOP development, as well as an understanding of quality principles • Good oral and written communication skills • Ability to work independently with little supervision • Demonstrated ability to define problems, collect data, establish facts and draw valid conclusions • Strong verbal and written communication skills • Must have above average problem-solving and decision-making abilities • Proficiency with computers • Must have explicit attention to detail • Must have excellent analytical skills, organization skills, and follow-up • Ability to read and interpret documents such as safety rules, operating and maintenance instruction, and procedure and technical manuals • Ability to interpret a wide variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables Physical Requirements • Use hands to handle or feel objects, tools, or controls; reach with hands and arms; and talk or hear • Frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee • Manual dexterity to perform all phases of donor plasmapheresis • Ability to stand for extended periods of time for up to four (4) hours at a time • Ability to sit for extended periods of time for up to (4) hours at a time and view a computer screen • Ability to lift, tug, pull up to fifty (50) pounds • Ability to travel by plane, or car as required to train or assist other centers as needed. Today, LFB is among the leading European bio-pharmaceutical companies providing mainly hospital-based healthcare professionals with plasma-derived or recombinant medicinal products in three major therapeutic areas: immunology, haemostasis, and intensive care. Life of patients is our purpose! Let's Work together in a climate of sharing, mutual exchange, trust and transparency. We are committed to hiring a diverse and talented workforce. AA/M/F/D/V. This organization participates in E-Verify.