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Manager of Quality Assurance

Company: Immunotek
Location: Nacogdoches
Posted on: June 13, 2021

Job 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

Core Values (Standards of Behavior)

To perform the job successfully, an individual should demonstrate the following:


* 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


* 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


* 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


* 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


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


* 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


* 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.


* 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 weeks per months for the fist 6 to 8 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

Keywords: Immunotek, Longview , Manager of Quality Assurance, Other , Nacogdoches, Texas

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