Supervisor, Quality Assurance

Supervisor, Quality Assurance

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.

The Supervisor, Quality Assurance is responsible for providing quality oversite to Quality Assurance team according to Minaris Quality policies, procedures, and standards. Provide oversite for material releases, final product releases; as well as assists Quality management with department needs. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. He/she helps the team understand performance targets and goals. Ensuring that workers are properly trained for their specific roles. Coordinating job rotation and cross-training

Essential Functions and Responsibilities

Provide oversight of QA floor support team.

Supervise, prioritizes, and coordinates the daily activities of the QA staff within the department

Facilitates internal training on quality assurance requirements, processes, and procedures.

Provides technical expertise to the client services team on tech transfer activities.

Must have knowledge in investigations, CAPA, change control and complaint process.

Manage Batch issuance and Batch Record Tracking System.

Review and approve Minaris SOPs, WIs, and Forms.

Supports QA teams with continuous improvements initiatives to enforce quality culture.

Initiate critical change control as required.

Assist gathering information for internal and external (e.g. cGMP, client, regulatory agencies) audits.

Support walk thru in preparation for internal and external (e.g. cGMP, client, regulatory agencies) audits.

Other duties as assigned.

Qualifications

Bachelor of Science in biological sciences or other relevant field of study

Minimum 5 years’ experience in QA in a life sciences company with a strong focus in the manufacturing and/or testing of biologics. Working knowledge and technical understanding of aseptic manufacture of biologics

Minimum 1-year supervisory experience. Equivalent combination of education and experience acceptable

Experience in both clinical and commercial manufacturing is preferred.

Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents MBR, reports, SOPS. Etc.

Experience in organizing teams for effective and timely completion of projects.

Understanding of quality system applications, including the use of electronic applications for training, deviations, CAPA management, etc.

Experience participating in or hosting health authority inspections and/or client audits.

Competencies/Candidate Profile

Relevant computer skills (Microsoft Office, Outlook)

Detail-oriented and organized

Analytical and problem-solving skills

Good written and oral communication skills

Ability to multi-task and be adaptable

Flexible and able to adapt to company growth and evolving responsibilities

Ability to work independently and with a team

Strong Project Management and organization skills

Confident in making decisions on non-routine issues

Supervisory Responsibility

Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.

Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems for the following positions. Directly supervised the following roles:

QA Associate I

QA Associate II

QA Associate III

Directly supervises 3-5 employees within the QA department.

Minimum Required Training to be Completed within first 90 days of hire

GXP training

SOP & WI training

Safety Training

GMP

Working Environment

Must have the ability to work in a team-oriented environment and with clients

Must be able to work during the weekend, holidays and as required by the company

May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids

Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc.

Understanding of quality system applications

Must be able to handle the standard/moderate noise of the manufacturing facility

Physical Requirements

Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear

The employee is frequently required to lift and/or move up to 30 pounds.

Direct Reports

3-5

Disclaimer

The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.