Manager of Quality Assurance

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.
• Other duties as assigned

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.

Knowledge, Skills, Abilities

• Ability to work independently with little supervision
• Ability to define problems, collect data, establish facts and draw valid conclusions
• Excellent verbal and written communication skills
• Proficiency with Microsoft Office software
• Must have explicit attention to detail
• 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.
• Maintain confidentiality of all personnel, donor and center information
• 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

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 train in plasma collection areas
• 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

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.

Education

• High School or better

• Masters or better
• Bachelors or better