Sr. Associate - Computer Systems QA

This role 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. This position will lead small/medium-scale projects or programs with small/moderate risk and/or complexity and provide assistance to cross-functional groups and/or management with troubleshooting investigations and problem resolution. Additionally, they will assist with implementation of quality improvement plans and provide QA presence in areas of responsibility (manufacturing, laboratories, IT, etc.) by conducting periodic walkthroughs. Ensures regulatory compliance and procedural consistency between manufacturing facilities. This role prepares cross-functional partners for Regulatory Inspections and provides assistance, where necessary, during regulatory/partner inspections. They will also ensure compliance observations associated with Celltrion Branchburg Manufacturing Facilities are adequately addressed and completed on schedule.

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

• Evaluate deviations and ensure appropriate root cause/likely assignable cause(s) and assess quality impact from Computer Systems Perspective. Recommend CAPAs and ensure CAPAs implemented are effective.
• Lead/Support investigation and evaluation of computer system related incidents and/or deviations.
• Review and approval of computer system related Standard Operating Procedures (SOP).
• Participate in the review and approval process for computerized system documentation and procedures.
• Evaluate computer related 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.
• Assist in activities associated with technology transfers to and from Celltrion Branchburg facilities, as applicable.
• Attend and serve as a key resource for computer systems issues in ad-hoc meetings to provide compliance guidance to Manufacturing, Facilities, Validation, IT. 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 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 (Data/System).
• Serve as a lead auditor during audits of software suppliers and/or computer-related service providers, when required.
• Must have a thorough understanding of computer systems validation as outlined in GAMP or an understanding of the System/Software Development Life Cycle concepts.
• Always comply with Site Safety Requirements.

Manage Relationships with Key Stakeholders and Customers:

• Support Site Process Teams and Site Flow Teams when required.

Do you have experience in Stakeholder management?, * 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 Engineering or 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).

Pulled from the full job description

• Health insurance
• Retirement plan
• Paid time off
• Vision insurance
• Dental insurance
• Life insurance
• Disability insurance, This role is exempt and the anticipated compensation for this role is $87,000 - $147,000. 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 5% travel and on-call availability. 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.