Quality Assurance Associate Level II
Skills : Batch records review, Documentation management, CAPA, Non-conformance, Deviations.
Referral reward:$250Job type:Direct hireJob function:Quality AssuranceIndustry:BiotechnologyExperience level:AssociateEducation level:Bachelor’s degreeJob classification:TechnicalLocation:Allendale, NJZip code:07401Skills:Batch records review, Documentation management, CAPA, Non-conformance, DeviationsExperience required:3 YearsRelocation assistance:NoVisa requirement:Only US citizens and Greencard holders,EAD cardsclose
Responsible to perform 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.
Essential Functions and Responsibilities
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.
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
Minimum Required Training To Be Completed within the first 90 Days of hire
SOP & WI training
This job has no supervisory responsibilities.
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
Must be able to handle the standard/moderate noise of the manufacturing facility
Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear
The employee is frequently required to lift and/or move up to 30 pounds and occasionally move tanks up to 300 pounds (with assistance)
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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