Principal Associate-Lab Operations Quality Assurance

Celltrion Branchburg, LLC•Branchburg Township, NJ

1d•$87,000 - $147,000

About The Position

This position works within the Celltrion Branchburg Process Team environment per Manufacturing Standards for Operational Excellence (MSOE), resolves key technical/quality problems and drives solutions that impact the site. This role will lead small/medium-scale projects or programs with small/moderate risk and/or complexity and air cross-functional groups and/or management with troubleshooting investigations and problem resolution. Additionally, this role will assist with implementation of quality improvement plans and provide QA presence in areas of responsibility (manufacturing, laboratories, FUME, etc.) by conducting periodic walkthroughs. This role also ensures regulatory compliance and procedural consistency between manufacturing facilities, prepares cross-functional partners for Regulatory Inspections and provides assistance, where necessary, during regulatory/partner inspections. This position ensures compliance observations associated with Celltrion Branchburg Manufacturing Facilities are adequately addressed and completed on schedule.

Requirements

Must possess working knowledge of domestic and international GMP regulations and other policies/regulations as applicable.
Must have experience in developing, reviewing and/or approving the following types of development/validation documents: Validation Plans, User/Functional Requirement Specifications, IQ/OQ/PQ Protocol and Reports, Requirements Traceability Matrix, and Validation Summary Reports.
Must possess a conceptual understanding of all Quality functions and business areas.
Must possess depth and/or breadth of expertise within area of responsibility.
Must have the ability to function in a fast-paced environment and communicate effectively with management.
Must be able to work in a cross-functional environment.
Must have demonstrate ability to work independently.
Must be proficient in Microsoft applications.
BA/BS degree in the sciences with a minimum of 1-3 years of experience in the Biopharmaceutical industry. Previous technical experience should be in biotechnology manufacturing processes and/or computer systems (large scale cell culture, purification processes, validation).

Nice To Haves

Previous experience in Quality Assurance is preferred.
Working knowledge of QC Microbiology and/or bioassay techniques is preferred.

Responsibilities

Evaluate deviations and ensure appropriate root cause/likely assignable cause(s) and assess quality impact.
Recommend CAPAs and ensure CAPAs implemented are effective.
Review and approve respective routine, development, and validation documentation.
Evaluate change controls and associated risk assessments.
Perform training within group or throughout organization as needed.
Write/escalate Notifications to Management, as applicable.
Ensure timely completion of all quality plan objectives and milestones. Support the on-time performance metrics.
Assist in creating quality metrics. Keep Quality management informed of compliance issues.
Perform periodic walk-throughs in Quality Control labs.
Assist in activities associated with technology transfers to and from Celltrion Branchburg facilities, as applicable.
Attend and serve as a key resource in ad-hoc meetings to provide compliance guidance to Manufacturing, Facilities, Validation, Computer Systems issues. Support lot release through ensuring timeliness resolve of compliance issues, as applicable.
Ensure compliance with applicable regulatory guidelines and GxP computer systems to global electronic records/signatures regulations (21 CFR Part 11, Annex 11, etc. as applicable).
Perform review of regulatory submissions as necessary.
Perform the compliance and risk evaluation of respective systems and departments.
Participate in internal audits performed by partners, Celltrion corporate, and/or regulatory agencies, as applicable.
Identify and lead a process improvement projects that impact systems used in a specific functional area.
Serve as core member on Process Team(s), a cross functional group charged with making medicine, continuous improvement, and site support in accordance with Manufacturing Standards of Operational Excellence.
Serve as key Quality liaison between disposition and compliance by supporting lot release through ensuring timeliness resolve of compliance issues, as applicable.
Perform and/or support Audit Trail Reviews.