Manager of Quality Assurance

The Manager of Center Quality Assurance is responsible for the daily oversight of the center's Quality Management system and Training Program to ensure regulatory compliance with ImmunoTek’s Operating procedures and all applicable entities. This Manager of Center Quality Assurance is also responsible for supporting strategic and quality compliance in all areas/functions of the donor center to ensure optimal inspection readiness, including appropriate preparation to enable favorable execution of all appropriate regulatory mitigations to ensure compliance and continuous improvement.

We offer a comprehensive benefits package designed to support your health, financial security, and work-life balance. Here’s a snapshot of the benefits you can expect:

-  Medical Benefits: Choose from multiple plans to access preventive care, extensive provider networks, and affordable prescription medications, with options for Health Savings Accounts (HSAs).

-  Dental and Vision Benefits: Affordable coverage for routine and specialized dental care, along with vision benefits covering exams, lenses, and frames.

-  Retirement Planning: Our 401(k) plan includes a company match to help you build a secure retirement.

-  Employee Assistance Program: Receive confidential counseling and guidance for personal challenges, legal and financial issues, and more.

-  Employee Discount Program: Save on a wide range of products and services through our partnerships.

-  Additional Incentives: Life and Accidental Death and Dismemberment (AD&D) Insurance as well as Voluntary Short-Term and Long-Term Disability Insurance options.

-  Bonus Opportunities: This position is eligible to participate in our bonus program.

Essential Job Responsibilities and Duties  

• Responsible for the personnel functions of the Quality Technicians and Supervisor of Quality and Training; including directions, assignment of work, development and training, disciplinary action, termination, maintenance of all personnel records, management of work schedule and delegation/follow-up of tasks.
• Ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations.
• Complete all Quality and Training Tasks in the absence of Quality Technician or Supervisor of Quality and Training Supervisor.
• Oversight of all aspects of internal and external audits this includes documentation, review preparation of the responses, implementation of corrective and preventative action, effectiveness checks of CAPA's, ensure established guidelines are met and follow-up as required.
• Facilitate and evaluate equipment readiness
• Verify and manage product, sample, and waste shipments
• Receive, approve and release donor center supplies.
• Works in collaboration with Center Management to develop the staff’s knowledge of their job function and to ensure training is conducted and completed according ImmunoTek' s Training Program.
• 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.
• Documents and tracks the center’s quality and operational metrics with respect to applicable SOPs and follow-up on incidents/errors as required; reports critical incidents and problematic trends to center management.
• 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).
• Interprets and Implements processes, and SOPs for quality control and overall regulatory compliance, making independent decisions and modifications as required.
• Promote Safety, Health and Environment Policies & Procedures. Ensure safety training and safety practices are implemented and followed within the center.
• Receive and provide feedback to staff on observations leading to improved adherence to GMP standards. Coach and develop area personnel regarding concerns or deficiencies. Report area personnel concerns or deficiencies to area management immediately. Make recommendations for remedial actions to resolve audit observations and other non-compliance issues of deficiencies.
• Ensure that the centers Quality and Training Program maintain compliance with all state, federal, European regulations in a Current Good Manufacturing Practice (cGMP), environment.
• Participate with management to develop programs and methods to streamline center processes resulting in improved customer/donor service, product yields and financial results while maintaining compliance and quality.
• Create appropriate organizational environment and value system which stimulates the morale and productivity of the work force and its leadership.
• Adhere to all HR policies and practices through fair and equitable treatment of all employees.
• Learn and maintain thorough familiarity and compliance with all state and federal regulations, Standard Operating Procedure Manual, Occupational Safety and Health Administration (OSHA), Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice (cGMP), and internal Company Procedures.
• Thorough knowledge of applicable Company and departmental policies and procedures as well as the willingness to learn and follow any policy or procedure that may be introduced in the future.
• Maintain an open line of communication with Management.
• Ensure and maintain the confidentiality of all personnel, donor, and center information.
• Maintain a positive and professional demeanor during all interactions with donors, fellow employees, and vendors.
• Ability to accept performance feedback in a professional manner.
• Regular attendance and arriving on time to all scheduled shifts and mandatory meetings.
• Other duties as assigned
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Qualifications

• Bachelor’s degree in a related discipline or four (4) years of equivalent experience in a regulated environment required
• Minimum 1 year supervisory, leadership experience responsible for overseeing the activities of others preferred.

Requirements

• Ability to interpret a wide variety of technical instructions
• Ability to work with a team and collaborate with others
• Strong leadership/supervisory skills
• Strong understanding of Quality Systems and/or regulated training requirements
• Communicate effectively with HR to ensure HR compliance
• Ability to comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA
• Ability to train in plasma collection areas
• Strong analytical, problem-solving, and organizational skills
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Demonstrate discretion when dealing with confidential information
• Ability to work on multiple projects concurrently
• Ability to work independently and manage deadlines efficiently
• Excellent verbal and written communication skills

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
• Ability to sit for extended periods for up to four (4) hours at a time
• Ability to lift, tug, and pull up to fifty (50) pounds

Work Environment

• A typical work environment with moderate noise level
• May be exposed to freezing temperatures for short periods of time
• Occupational exposure to bloodborne pathogens

Disclaimer
This job description is construed to indicate the general nature and level of work performed. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required.