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

Our Biotechnology client seeks a Quality Assurance Associate II responsible for performing Quality Assurance activities under direct supervision of daily tasks in support of Quality Systems and/or client procedures including but not limited to document management, review of QC data, material releases and final product releases as well as assisting Quality management with department needs.

• Ensures that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical and commercial manufacturing.
• Read, understand and follow all cGMP and cGTP documentation for Quality System Functions (SOPs,WIs,etc.)
• Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical and commercial manufacturing.
• Release raw material in ERP system as well as on paper.
• Perform Accessioning of incoming Apheresis.
• Review Batch record and disposition material of finished product to client.
• Provides information for Out of Specification and deviations to investigator.
• Performs line clearance prior to manufacturing operations begins.
• Supports tech transfer activities.
• Other duties as assigned.

REQUIREMENTS

• BS or higher education degree in a scientifically related field
• Experience in a biologics or biotechnology company (1 -3 years)
• Working knowledge and technical understanding of the aseptic manufacture of biologics preferred
• Working knowledge of GMP and TCTP regulations
• Experience in reviewing GMP/GCTP related documents (validations/qualifications reports, SOPs, etc)
• 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, prioritize, time manage and be adaptable
• Flexible and able to adapt to company growth and evolving responsibilities
• Ability to work independently and with a team

Working Environment

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, and liquid nitrogen
Must have the ability to work with specialized equipment