Manager Center Quality Assurance

LFB•Fort Pierce, FL

About The Position

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.

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

Nice To Haves

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.

Responsibilities

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