Our Biotechnology client seeks a Quality Assurance Associate III to perform 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. 

• Schedules batch record process for all floor associates in accordance with kitting schedule.
• Facilitates internal training on quality assurance requirements, processes, and procedures.
• Provides technical expertise to the client services team on tech transfer activities.
• Provides supportive documents to investigators and/or compliance team.
• Conducts final verification of batch records prior to archiving; sends records to document control; Review of executed APS reports/ batch records.
• Draft SOPs, WIs, and Forms for revision.
• Supports QA teams with continuous improvements initiatives to enforce quality culture.
• Initiate 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. 

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
• 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.
• 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 
• 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

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices industries in New Jersey.

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