Quality Assurance Associate III

Job Description Job Description Quality Assurance Associate III Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Device, IT & Human Resources disciplines in New Jersey. The Quality Assurance Associate III is responsible for performing Quality Assurance activities within minimal supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, issuance, review and approval of batch records, SOPs, Qualification and Validation Reports; review of QC data; perform material releases and final product releases; review of Deviations 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. This role manages internal and external audits which may include interaction with Health Authorities and clients

• Interfaces directly with client and cross functional teams
• Provides resolutions pertaining to quality for project related issues
• Independently prioritize, schedule, and manage multiple projects and resources (team)
• Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements.
• Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs
• Able to provide input based on knowledge and experience on quality systems and procedures and CGMP/GTP issues.
• Author and review relevant SOPs, validation and other documents.
• Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports.
• Responsible for the completion of all client requirements related to cellular product and/or material releases.
• Master Batch Record Control, distribution and label verification
• Perform line clearance activities as required.
• Assignment and maintenance of product Lot numbers as applicable.
• Perform internal documentation audits as assigned.
• Materials management nonconformance disposition and release activity as applicable.
• Responsible for accurate deviation reporting as applicable and tracking/trending follow up actions to closures
• Evaluate and investigate deviation reports and initiate and coordinate corrective and preventive actions.
• Track and trend relevant quality metrics including environmental monitoring data.
• Provide Quality Assurance related support to various departments.
• Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies.
• Electronic Document Control activities as assigned.
• Provide training to personnel as assigned by supervisor.
• Travel may be required.

REQUIREMENTS

• BS in biological sciences or other relevant field of study
• 5 years + experience in QA in a life sciences company company with a strong focus in the manufacturing and/or testing of biologics.
• Working knowledge and technical understanding of aseptic manufacture of biologics
• Understanding of quality system applications
• Experience in both clinical and commercial manufacturing is preferred.
• Experience in authoring, reviewing, and /or approving cGMP/cGTP related documents (validation/qualification 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.
• 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
• 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 fluidsMust utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, etc. 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.