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

Celltrion Branchburg, LLC; Branchburg Township (NJ); Hybrid; USD 71,000 - 119,000; Full time

Benefits offered by this job

Paid time off

Medical, dental, vision insurance

Company retirement plan

Wellness programs

Disability benefits

Job summary

Celltrion Branchburg, LLC seeks an Associate in QA Manufacturing Operations for a Wed-Sat night shift in Branchburg, NJ. The role focuses on GMP compliance, deviations, CAPA, MES review, and batch record verification.

Collaborative, detail-oriented candidates who thrive in a fast-paced biotech setting are encouraged to apply. The position involves supporting technology transfers, audits, and timely issue escalation, with exposure to regulatory guidelines and 21 CFR Part 11 compliance.

Qualifications

• Must possess working knowledge of GMP regulations and policies.
• Ability to function in a fast-paced environment and communicate with management.
• Ability to work in a cross-functional team environment.
• Ability to work independently and take initiative.
• Proficient in Microsoft applications (Office).
• Prior technical or QA experience in biotechnology manufacturing preferred.

Responsibilities

• Support Process Teams and provide guidance on quality issues.
• Evaluate deviations and ensure root cause analyses and CAPA effectiveness.
• Timely elevate issues to management as applicable.
• Perform data integrity analysis and Audit Trail Reviews.
• Perform MES exceptions / batch record review.
• Support lot release and regulatory inspections as needed.
• Assist in technology transfers and review development/validation docs.

Skills

GMP Regulations Knowledge

Cross-functional Teamwork

Communication Skills

Independent Working

Microsoft Office

Biotech QA Experience

Education

BA/BS in hard sciences

Tools

MES

QMS Systems

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

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

Full Time Branchburg, NJ, US

12 days ago Requisition ID: 1145

Salary Range: $71,250.00 To $118,750.00 Annually

Position Brand Description

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.

Manage for Results /Strategic Planning

• Support and provide guidance to 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.
• T imely elevate issues 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.

QA MFG (2nd Shift)

• 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.

Basic 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.
• Previous technical or QA experience in biotechnology manufacturing processes and/or computer systems (large scale cell culture, purification processes, validation) is preferred.

Additional Preferences

• 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.

Education Requirements

• 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.

This role is exempt and the anticipated compensation for this role is $71, 250 - $118,750.

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.