Principal Associate QA Lab Compliance

Position Brand Description:  This position independently 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.  Leads medium-scale projects or programs with moderate risk and/or complexity. This position provides assistance to cross-functional groups and/or management with troubleshooting investigations and problem resolution. Additionally, this role assists with implementation of quality improvement plans.  Provides Quality Assurance 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 and prepares cross-functional partners for Regulatory Inspections. This role provides assistance, where necessary, during regulatory/partner inspections and ensures compliance observations associated with Celltrion Branchburg Manufacturing Facilities are adequately addressed and completed on schedule. As applicable, this position is responsible for partnering with the Quality Leader and Quality Leadership staff to lead quality culture initiatives with high visibility and/or complexity resulting in increased capability, employee engagement, and improved business results and outcomes. This role is also responsible for authoring quality sections of Annual Product Review, Quality Metrics analysis and presentation at Quality Lead Team and other relevant process/flow teams. This individual can be the site process owner for quality compliance processes (e.g. deviation, change, APR, notification to management etc.).    Key Objectives/Deliverables:  Manage for Results /Strategic Planning:  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.   Basic Requirements:  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   Additional Preferences:  Ability to independently work with others, as applicable.  Laboratory experience preferred, as applicable.    This role is exempt and the anticipated compensation for this role is $110, 250 - $170,000  This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.  Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits. This role requires up to 10% travel, on-call availability, and may involve shift work. Hybrid work flexibility may be available based on business needs; relocation assistance is not provided.   Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.