Quality Assurance Associate III

4 weeks ago

Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time
Job Description

At Lynkx Staffing LLC, we are seeking a highly skilled Quality Assurance Associate III to join our team. As a Quality Assurance Associate III, you will be responsible for performing quality assurance activities within minimal supervision of daily tasks in support of quality systems and/or client procedures. This includes document management, issuance, review, and approval of batch records, SOPs, qualification and validation reports, review of QC data, material releases, and final product releases. You will also assist quality management with department needs and exercise 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.

Responsibilities

Interfaces directly with client and cross-functional teams
Provides resolutions pertaining to quality for project-related issues
Independently prioritizes, schedules, and manages multiple projects and resources (team)
Ensures the safe release of cellular products in accordance with company and/or client procedures and requirements
Ensures and promotes 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
Authors and reviews 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
Performs line clearance activities as required
Assigns and maintains product lot numbers as applicable
Performs 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
Evaluates and investigates deviation reports and initiates and coordinates corrective and preventive actions
Tracks and trends relevant quality metrics, including environmental monitoring data
Provides quality assurance-related support to various departments
Interfaces 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
Provides 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 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

Working Conditions

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.

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.

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