Celltrion Inc · 13 hours ago
QA Lab Compliance Technical Lead
Branchburg, NJ
Full-time
Hybrid
Mid, Senior Level
$128K/yr - $170K/yr
3+ years expCelltrion Inc is a biopharmaceutical company seeking a QA Lab Compliance Technical Lead to work within their Process Team environment. This role involves resolving technical and quality problems, ensuring regulatory compliance, and leading quality culture initiatives while managing various quality assurance responsibilities.
Health CarePharmaceutical
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 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 and area changeovers of Manufacturing facilities
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 Branchburg corporate, and/or regulatory agencies, as applicable
Partner with cross-functional groups and management with inspection readiness activities and will interact with the FDA and other regulatory agencies, as required
Identify and lead a process improvement projects that impact systems used in a specific functional area
Serve as a 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 Analysis Audit Trail Reviews
Qualification
Required
BA/BS degree in the sciences with a minimum of 3-5 years 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)
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
Preferred
Ability to independently work with others, as applicable
Laboratory experience preferred, as applicable
Benefits
Paid time off (holidays, vacation, and additional leave)
Medical, dental, and vision insurance
Life insurance
A company-matched retirement savings plan
Wellness programs
Short- and long-term disability benefits
Company
Celltrion Inc
Celltrion is a leading biopharmaceutical company that specializes in research, development and manufacturing of innovative therapeutics.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2023-08-17Acquired
2017-07-28IPO
Recent News
2025-12-31
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