What are the responsibilities and job description for the Manager, Center QA position at LFB?
Essential Job Responsibilities and Duties
Requirements
Physical Requirements
- 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
- Bachelor’s Degree in a scientific discipline, life sciences or related discipline preferred or
- 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.
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