What are the responsibilities and job description for the Supervisor, QC Analytical position at Minaris Regenerative Medicine?
At Minaris Regenerative Medicine our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.
This position will report into the Manager of QC Analytical. The QC Analytical Supervisor will organize, and direct staff to meet and exceed cGMP requirements, and establish KPI’s, while adhering to quality control and technical standards. The QC Analytical Supervisor will also provide oversight of day to day activities including adjustment of workflow, test performance, and quality compliance.
The Supervisor, QC Analytical will lead Quality staff members across various shifts.
Essential Functions And Responsibilities
Below is the summary of the role responsibilities. This is not an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.
Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
Schedules and monitors daily operation of department based on projected client demands.
Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.
Approval of investigations and documentation of non-confirming events and OOS.
Recommends process improvements to achieve greater efficiency within the department and between sites.
Participates in department and cross functional meetings.
Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness.
Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.
Other duties as assigned.
Qualifications
Bachelor’s degree in Science or relevant field; Minimum of 7 years of experience with analytical laboratory or within the biopharmaceutical industry or equivalent.
Strong knowledge of FDA and EU regulatory standards. cGMP experience required.
Strong knowledge of analytical test methods and philosophies.
Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.
Proficient with computer software with MS Office and LIMS
Competencies/Candidate Profile
Acts decisively
Exercises good judgment and makes effective, sound, timely and informed decisions. Seeks to identify, analyze and resolve problems effectively.
Builds and maintains relationships
Strong collaborative and influencing skills and ability to work well in a matrixed environment with internal and external stakeholders.
Communicates effectively
Uses appropriate modes and media, targeting the amount, level of detail, and content of the information to the needs of the audience. Prepares clear, concise, and well-organized written documents and oral presentations. Conveys information clearly, confidently, and with the proper tone. Facilitates open communication. Uses discretion and demonstrates sensitivity to confidentiality concerns. Listens effectively and provides appropriate feedback.
Fosters continuous improvement and innovation
Promotes efforts aimed at improving current business processes through a culture that fosters continuous improvement and innovation. Identifies and implements improvements and innovations that increase efficiency and enhance work quality. Promotes ongoing development of staff and takes initiative to assess and self-develop supervisory competencies.
Fosters integrity and honesty
Displays and fosters integrity and honesty through the promotion of mutual trust and respect, demonstrates and fosters high ethical standards, and treats others fairly and ethically.
Supervises and manages performance
Builds and manages a multi-sector workforce based on organizational goals, budget considerations, and staffing needs. Ensures staff are recruited and selected using merit principles. Ensures tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements and holding staff accountable for meeting expectations. Trains and develops staff, provides constructive performance feedback and appraisals, and takes appropriate corrective action to address performance and conduct issues.
Manages projects and functions
Manages projects and leads initiatives in the workplace. Organizes resources, people, and activities; and ensures collaboration and the achievement of project and function goals and targets. Ensures effectiveness and efficiency in the delivery of services, products and/or programs.
Supervisory Responsibility
Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees.
Provides oversight and direction to the employees in accordance with the organization's policies and procedures.
Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities.
Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback.
Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise.
Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization.
Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning.
Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication.
Quality Requirements
Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
Attend all required Quality & Compliance training at the specified interval.
Minimum Required Training
GxP/GDP Training
Safety Training
Working Environment
While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noise.
Must have the ability to work with specialized equipment.
This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. Noise level is moderate.
Physical Requirements
The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully.
An individual may exert up to 10 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects.
Must be physically capable to stand, walk, sit, bend, stretch, use hands to handle or feel, reach with hands and arms, and talk or hear
The employee is frequently required to lift, move, or carry up to 50 pounds and occasionally move tanks up to 300 pounds (with assistance).
Heavy cryo-gloves must be used when working with liquid nitrogen
This role is sedentary. An individual may occasionally exert up to 10 pounds of force or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects. Sedentary entails sitting most of the time but may involve walking or standing for brief periods.
Must be able to exchange information in person, on the telephone, and to make presentations.
Gowning proficiency as needed.
Must be capable of moving, sitting, stretching, stooping, using hands and fingers, reaching with hands and arms, talking and exchanging information, and vision sufficient to read materials.
Direct reports
QC Analysts (Approximately 8-10 reports)
Disclaimer
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Tuesday to Saturday (6 am to 2:30 pm)
This position will report into the Manager of QC Analytical. The QC Analytical Supervisor will organize, and direct staff to meet and exceed cGMP requirements, and establish KPI’s, while adhering to quality control and technical standards. The QC Analytical Supervisor will also provide oversight of day to day activities including adjustment of workflow, test performance, and quality compliance.
The Supervisor, QC Analytical will lead Quality staff members across various shifts.
Essential Functions And Responsibilities
Below is the summary of the role responsibilities. This is not an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.
Ensures compliance with regulatory agency requirements by enforcing a quality culture throughout the department.
Schedules and monitors daily operation of department based on projected client demands.
Conducts routine walkthroughs of the facility to ensure compliance with regulatory and quality practices.
Approval of investigations and documentation of non-confirming events and OOS.
Recommends process improvements to achieve greater efficiency within the department and between sites.
Participates in department and cross functional meetings.
Maintains audit readiness within the department by ensuring proper training of staff, reviewing documentation, and ensuring laboratory cleanliness.
Interacts with internal and external customers to ensure proper sampling, reporting, and resolution of questions and concerns.
Other duties as assigned.
Qualifications
Bachelor’s degree in Science or relevant field; Minimum of 7 years of experience with analytical laboratory or within the biopharmaceutical industry or equivalent.
Strong knowledge of FDA and EU regulatory standards. cGMP experience required.
Strong knowledge of analytical test methods and philosophies.
Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.
Proficient with computer software with MS Office and LIMS
Competencies/Candidate Profile
Acts decisively
Exercises good judgment and makes effective, sound, timely and informed decisions. Seeks to identify, analyze and resolve problems effectively.
Builds and maintains relationships
Strong collaborative and influencing skills and ability to work well in a matrixed environment with internal and external stakeholders.
Communicates effectively
Uses appropriate modes and media, targeting the amount, level of detail, and content of the information to the needs of the audience. Prepares clear, concise, and well-organized written documents and oral presentations. Conveys information clearly, confidently, and with the proper tone. Facilitates open communication. Uses discretion and demonstrates sensitivity to confidentiality concerns. Listens effectively and provides appropriate feedback.
Fosters continuous improvement and innovation
Promotes efforts aimed at improving current business processes through a culture that fosters continuous improvement and innovation. Identifies and implements improvements and innovations that increase efficiency and enhance work quality. Promotes ongoing development of staff and takes initiative to assess and self-develop supervisory competencies.
Fosters integrity and honesty
Displays and fosters integrity and honesty through the promotion of mutual trust and respect, demonstrates and fosters high ethical standards, and treats others fairly and ethically.
Supervises and manages performance
Builds and manages a multi-sector workforce based on organizational goals, budget considerations, and staffing needs. Ensures staff are recruited and selected using merit principles. Ensures tasks are appropriately delegated and completed by monitoring performance against predetermined standards and requirements and holding staff accountable for meeting expectations. Trains and develops staff, provides constructive performance feedback and appraisals, and takes appropriate corrective action to address performance and conduct issues.
Manages projects and functions
Manages projects and leads initiatives in the workplace. Organizes resources, people, and activities; and ensures collaboration and the achievement of project and function goals and targets. Ensures effectiveness and efficiency in the delivery of services, products and/or programs.
Supervisory Responsibility
Determines staffing levels; recruits, interviews, selects, hires, and employs appropriate number of employees.
Provides oversight and direction to the employees in accordance with the organization's policies and procedures.
Coaches, mentors, and develops staff, including overseeing new employee onboarding and providing career development planning and opportunities.
Empowers employees to take responsibility for their jobs and goals. Delegates responsibility and holds staff accountable by providing regular feedback.
Fosters teamwork and cohesiveness among department members; expeditiously initiates conflict resolution when issues arise.
Creates a workplace culture that is consistent with the mission, vision, guiding principles, and values of the organization.
Leads employees using a performance management and development processes to include goal setting, feedback, and performance development planning.
Appropriately communicates organization information through department meetings, one-on-one meetings, appropriate email, and regular interpersonal communication.
Quality Requirements
Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
Attend all required Quality & Compliance training at the specified interval.
Minimum Required Training
GxP/GDP Training
Safety Training
Working Environment
While performing the duties of this job, the employee may occasionally be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens. Other exposures may include gases (nitrogen), or corrosive chemicals (Clorox, potassium hydroxide), or exposure to liquid nitrogen. The noise level in the work environment is moderately noise.
Must have the ability to work with specialized equipment.
This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. Noise level is moderate.
Physical Requirements
The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully.
An individual may exert up to 10 pounds of force occasionally or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects.
Must be physically capable to stand, walk, sit, bend, stretch, use hands to handle or feel, reach with hands and arms, and talk or hear
The employee is frequently required to lift, move, or carry up to 50 pounds and occasionally move tanks up to 300 pounds (with assistance).
Heavy cryo-gloves must be used when working with liquid nitrogen
This role is sedentary. An individual may occasionally exert up to 10 pounds of force or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects. Sedentary entails sitting most of the time but may involve walking or standing for brief periods.
Must be able to exchange information in person, on the telephone, and to make presentations.
Gowning proficiency as needed.
Must be capable of moving, sitting, stretching, stooping, using hands and fingers, reaching with hands and arms, talking and exchanging information, and vision sufficient to read materials.
Direct reports
QC Analysts (Approximately 8-10 reports)
Disclaimer
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Tuesday to Saturday (6 am to 2:30 pm)
