The Quality Assurance (QA) / Control (QC) Manager is responsible for ensuring all personnel/aspects of the quality assurance and control functions of the department are cohesive and efficient. Along with supervising the QA/QC personnel, the QA/QC Manager shall ensure that donor eligibility chart review, label generation, batch record review, tissue irradiation, and real time quality product control is performed in alignment to Surgenex policies and applicable regulations and standards to provide quality, safety, and integrity of human tissues processed and distributed by Surgenex.
ESSENTIAL FUNCTIONS
The QA/QC Manager is responsible for ensuring all QA/QC staff are trained and competent to perform donor eligibility chart review, label generation, batch record review, tissue irradiation, real time quality product control and other position required job functions.
Supervises the QA/QC staff to ensure each of the functions are complete, accurate, and compliant and identify deficiencies and required corrections.
Directly supervises the QA/QC control personnel and work within the day-to-day operations to ensure compliant processes.
Train and educate Surgenex staff on QA and QC procedures and best practices.
Effectively communicates to the QA/QC staff their job responsibilities, time management, workflow, and communication.
Ensures QA/QC staff understand their job expectations and are informed in a timely manner when these expectations are not met. Applies use of disciplinary action when necessary. Promotes employee mentoring and coaching using documentation and management tools including Performance Improvement Plans (PIP).
Assists with recruiting, hiring, and training personnel.
In collaboration with the (Sr.) Director of QA/QC and department leadership will develop key performance metrics (KPI’s), analyze data and prepare reports to identify trends and opportunities for improvement.
Assist with development and implementation of quality assurance and quality control standard operating procedures.
Support the Regulatory department with accessing the compliance of operational and quality processes and addressing any potential opportunities for improvement and correction.
Stay updated on regulatory requirements for tissue banking, including state, local, federal and international regulations, and accrediting agency standards.
Actively participate in and contribute to continuous improvement initiatives within Surgenex.
Propose and implement improvements to quality processes for enhancement of efficiency and effectiveness.
Report, investigate and document in the electronic quality management system, any occurrences related to the tissue quality, Surgenex procedures and regulatory gaps identified and collaboratively develop effective corrective and preventive actions
Ensure staff compliance with quality management system procedures.
Other duties as assigned.
POSITION QUALIFICATIONS
Accuracy - Ability to perform work accurately and thoroughly.
Accountability – Ability to accept responsibility and account for his/her actions.
Active Listening - Ability to actively attend to, convey, and understand the comments and questions of others.
Adaptability – Ability to adapt to change in the workplace.
Analytical Skills – Ability to use thinking and reasoning to solve problems.
Autonomy – Ability to work independently with minimal supervision.
Coaching and Development – Ability to provide guidance and feedback to help others strengthen specific knowledge/skill areas.
Compliance – Ability of the individual to be in accordance with established guidelines, policy, standards, or legislation.
Communication – Ability to communicate clearly and concisely.
Conflict Resolution - Ability to deal with others in an antagonistic situation.
Customer Oriented - Ability to take care of the customers’ needs while following company procedures.
Detail Oriented - Ability to pay attention to the minute details of a project or task.
Diversity Oriented – Ability to work effectively with people regardless of their age, gender, race, ethnicity, religion, or job type.
Ethical – Ability to demonstrate conduct conforming to a set of values and accepted standards.
Honesty / Integrity - Ability to be truthful and be seen as credible in the workplace.
Judgment – Ability to formulate a sound decision using the available information.
Leadership – Ability to influence others to perform their jobs effectively and to be responsible for making decisions.
Management Skills – Ability to organize and direct oneself and effectively supervise others.
Organized - Possessing the trait of being organized or following a systematic method of performing a task.
Problem Solving – Ability to find a solution for or to deal proactively with work-related problems.
Responsible - Ability to be held accountable or answerable for one’s conduct.
Team Builder – Ability to convince a group of people to work toward a goal.
Technical Aptitude – Ability to comprehend complex technical topics and specialized information.
Time Management - Ability to utilize time efficiently and meet deadlines.
Tolerance – Ability to work successfully with a variety of people without making judgements.
SKILLS & ABILITIES
Education: Bachelor's Degree in a relevant scientific field; biology, biotechnology, medical technology, etc. Equivalent work experience may be substituted for education. Experience: Tissue banking or related healthcare or biotechnology industry.
Computer Skills: Proficient with Macintosh / Apple and Google computer systems and applications. Certificates & Licenses: None, AATB - CTBS preferred
Surgenex® is an industry leading biotechnology firm focused on the development and commercialization of placental tissue and musculoskeletal based implants meeting stringent quality and safety standards.
We offer a full suite of processing capabilities to supply traditional birth tissue and musculoskeletal allografts through customized, innovative implants.
Our dedicated team of professionals focuses on exceeding expectations by combining in-depth industry experience and a robust quality system to deliver exceptional quality, best in class customer service, and a commitment to on time delivery.