Associate - QA Manufacturing Operations Wed-Sat: 2pm-12:30am

Celltrion Branchburg, LLC•Branchburg Township, NJ

3d•$71,250 - $118,750•Hybrid

About The Position

The Quality Assurance Manufacturing Associate independently works within the Celltrion Branchburg Process Team environment to ensure Quality Systems and GMP compliance. This position aids and provides guidance to Process Teams in deviation investigations, change control assessments, procedure and master production record revisions, validations and MES exceptions /batch record review. Also, this role provides QA presence in Manufacturing areas by conducting periodic walkthroughs and aids, where necessary, during regulatory/partner inspections.

Requirements

Must possess working knowledge of domestic and international GMP regulations and other policies/regulations as applicable.
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 team environment.
Must have demonstrate ability to work independently.
Must be proficient in Microsoft applications.
BA/BS degree in the hard sciences with a minimum of 1-3 years experience in the Biopharmaceutical industry. Preference for Chemistry, Biology, Biotechnology, Microbiology, Biochemistry, and Chemical/Biological Engineering.

Nice To Haves

Previous technical or QA experience in biotechnology manufacturing processes and/or computer systems (large scale cell culture, purification processes, validation) is preferred.
Strong understanding of data integrity principles and resolution of data integrity lapses.
Prior experience with quality management systems (deviation, change control, CAPA, activity planning) preferred.
Strong technical understanding of biotechnology processes preferred.

Responsibilities

Support and provide guidance to Downstream Process Team(s) and other customers.
Evaluate deviations are raised where required and ensure appropriate root cause/likely assignable cause(s) and assess quality impact. Recommend CAPAs and ensure CAPAs implemented are effective.
Write/escalate Notifications to Management, as applicable.
Perform periodic walk-throughs and support area changeovers of Manufacturing facilities.
Perform Data Integrity Analysis and Audit Trail Reviews.
Perform MES exceptions /batch record review.
Perform training within group or throughout organization as needed.
Attend and serve as a key resource in ad-hoc meetings to provide compliance guidance to Manufacturing issues.
Support lot release through ensuring timeliness resolve of compliance issues, as applicable.
Assist in activities associated with technology transfers to and from Celltrion Branchburg facilities, as applicable.
Review and approve respective development and validation documentation.
Identify where change controls are required, evaluate change controls and associated risk assessments.
Support applicable on-time performance metrics.
Support audits performed by partners, Celltrion corporate, and/or regulatory agencies, 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).
Support floor time program and resolution of issues identified.
Escalate critical quality issues to management.
Coordinate with second shift Process Team representatives to resolve issues in real time and ensure compliance to procedural requirements and proper documentation.