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Quality Assurance Manager

3 months ago

Greenacres City, Florida, United States LFB Full time
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 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 selfassessments 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 problemsolving and decisionmaking abilities
  • Proficiency with computers
  • Must have explicit attention to detail
  • Must have excellent analytical skills, organization skills, and followup
  • 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.