Our growing, global, biotechnology CDMO client specializing in Cell and Gene Therapy products seeks a Supervisor, Quality Assurance who will be responsible for providing quality oversite to Quality Assurance team according to 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.

• 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.
• Provide 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 SOPs, WIs, and Forms.
• Support 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.
• Directly supervise 3-5 employees within the QA department. 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.
• Other duties as assigned.

REQUIREMENTS

• Bachelor of Science in biological sciences or other relevant field of study
• 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
• Qualifications
• 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.
• 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
• Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Understanding of quality system applications

Working Environment

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

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.

Lynkx Staffing specializes in placing Biotechnology, Pharmaceutical, Medical Devices, IT & Human Resources professionals in New Jersey.

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