Manager of Quality Assurance
Employment Type : 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 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
Core Values (Standards of Behavior)
To perform the job successfully, an individual should demonstrate the following:
Passion
- Approach the workday with vigor and enthusiasm
- Showcase positivity in actions, thoughts, and communication with colleagues, employees, and donors
- Driven by the purpose of enhancing the lives of our patients through expert plasma collection
Leadership
- Operate with integrity by doing the right thing every time
- Utilize effective communication to set expectations
- Seek to understand barriers through the identification of root causes and take corrective action
- Showcase open mindedness in search of the best ideas and talents
Accountability
- Hold themselves responsible in regard to their performance and behavior
- Showcase transparency and honesty in all interactions
- Possess follow-up and follow-through
Service Excellence
- Going above and beyond to ensure that our people receive timely and accurate service
- Ensuring that all employees are equipped with the proper knowledge and training needed to meet the expectations of their jobs
- Seek what is best for the company versus what is best for self
Mutual Respect
- Treating people with courtesy, politeness, and kindness
- Showcasing receptiveness to diverse thoughts and opinions of others by fostering an environment of inclusion
- Steering clear of behavior that insults, belittles, or undermines the beliefs of others
Ambition
- Defy the odds by creating a culture of openness, engagement, and opportunity
- Remain steadfast to the purpose
- Continuously set the bar high for ourselves and those that we service
Competencies
The competencies below identify the knowledge, skills, and abilities or other behaviors critical to success in this role:
Attention to Detail
- Diligently attends to details and pursues quality in accomplishing tasks
Analysis/Reasoning
- Examine data to grasp issues, draw conclusions, and solve problems
Quality Focus
- Setting high-quality standards and striving for continuous improvement and quality assurance
Systems Judgment
- Ability to be balanced in getting things accomplished within the external system of people and things within which you work; an affinity for schematic thinking
Influencing Others
- Influence others to be excited and committed to furthering the organization’s objectives; ability to gain other’s support for ideas, proposals, and solutions
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
Travel Requirement
Travel up to 3 consecutive weeks per months for the fist 5 to 6 months prior to the Center opening for training.
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.
Work Environment
- Typical work environment with moderate noise level
- May be exposed to freezing temperatures for short periods of time
- Occupational exposure to bloodborne pathogens
Benefits Summary
- Medical, Dental, and Vision Insurance
- HSA (Health Savings Account)
- PTO (Paid Time Off)