Supervisor, Quality Assurance

Minaris•Allendale, NJ

6d•Onsite

About The Position

The Supervisor, Quality Assurance is responsible for providing quality oversight to the Quality Assurance team according to Minaris Quality policies, procedures, and standards. This role provides oversight for material releases, final product releases, and assists Quality management with department needs. The supervisor exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. They help the team understand performance targets and goals, ensuring that workers are properly trained for their specific roles and coordinating job rotation and cross-training.

Requirements

Must have knowledge in investigations, CAPA, change control and complaint process.
Regular and reliable attendance on a full-time basis.
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.
GXP training SOP & WI training Safety Training
Supports a diverse and inclusive culture and workforce, ensures compliance with laws, regulations, and company policies.
Identifies, recruits, and retains top-notch talent.
Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance management.
Develop employees to meet both their career and organizational goals.
Builds strong customer relationships and delivers customer-centric solutions.
Maintains transparent communication, appropriately communicates organizational information through department meetings, one-on-one meetings, email, and regular interpersonal communication.
Comfortable working in ambiguous situations and adaptable to change.
Must model the highest degree of moral and ethical behavior and maintain confidential information.
High degree of autonomy and strong decision-making skills.
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
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 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.
Relevant computer skills (Microsoft Office, Outlook)
Experience participating in or hosting health authority inspections and/or client audits.
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 and are expected to utilize universal precautions with all human specimens
Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
Must be able to handle the standard/moderate noise of the manufacturing facility
May work with hazardous materials and chemicals

Nice To Haves

Experience in both clinical and commercial manufacturing is preferred.

Responsibilities

Provide oversight of QA floor support team.
Supervise, prioritize, and coordinate the daily activities of the QA staff within the department.
Facilitate internal training on quality assurance requirements, processes, and procedures.
Provide technical expertise to the client services team on tech transfer activities.
Manage Batch issuance and Batch Record Tracking System.
Review and approve Minaris SOPs, WIs, and Forms.
Support QA teams with continuous improvement 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-throughs in preparation for internal and external (e.g., cGMP, client, regulatory agencies) audits.
Ensure compliance with all FDA and Worldwide Quality & Compliance regulations.
Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity.
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.