Quality Assurance Associate II

Minaris • Allendale, NJ

8d

About The Position

The Quality Assurance Associate II (1st Shift, Tuesday-Saturday, 8:00 am- 4:30 pm) is 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. Regular and reliable attendance on a full-time basis. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture.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. Other duties as assigned.

Requirements

• 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
• BS or higher education degree in a scientifically related field
• Experience in a biologics or biotechnology company (1 -3 years)
• Working knowledge of GMP and TCTP regulations
• Experience in reviewing GMP/GCTP related documents (validations/qualifications reports, SOPs, etc.)

Nice To Haves

• Working knowledge and technical understanding of the aseptic manufacture of biologics preferred

Responsibilities

• Perform Quality Assurance activities under direct supervision of daily tasks in support of Quality Systems and/or client procedures
• Document management
• Review of QC data
• Material releases and final product releases
• Assist Quality management with department needs
• Exhibit professional behavior with both internal and external business associates
• Ensure 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
• Provide information for Out of Specification and deviations to investigator
• Perform line clearance prior to manufacturing operations begins
• Other duties as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level