Summer Internship: QA Manufacturing Intern (Onsite - Hopewell, NJ)

BeiGene•Hopewell, NJ

1d•Onsite

About The Position

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Internship program dates: June 8 - August 21, 2026 Education Required: Bachelor of Science Degree In Progress in a related scientific discipline General Description/Scope of Responsibilities (Internship): This position is based in Hopewell, NJ. Supports QA material inspection and QA Manufacturing activities, ensuring the successful day to day operations by supporting: logbook and documentation reviews, material inspection activities, document reviews, material complaint support, shop floor observations, and related Quality support activities. Works to support QA Key Performance Indicators (KPIs) such as SOP mandated cycle times, on time closure dates, and QA objectives, whilst adhering to regulatory compliance and achieving business success. Creates and/or reviews SOPs need to support the business. Supports QA related tasks as assigned by QA Management. Essential Functions of the job: Ensuring all activities are performed in accordance with GMPs, SOPs and Health and Safety policies. Gowns into classified areas to observe manufacturing operations in drug substance and drug product manufacturing. Performs facility GEMBAs Redline procedures and GMP documentation for future revision and process improvement initiatives Supports Warehouse and Material Release QA with material inspection against approved specifications. Supports specification review. Reviews GMP documentation for compliance with site procedures. Generates KPI metrics for department, as needed Supports Quality Assurance activities to ensure compliance with FDA/EU regulations. Supports QA compliance of departmental SOPs (writing and/or revising), ensuring regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially. Awareness of USP/EP, ICH Guidelines, QC methodology updates to ensure compliance with current testing and specifications. Ensuring appropriate escalation and follow up for non-conformities within GMP areas. Ensuring that the Quality department meets or improves key performance indicators (KPIs). Undertaking any other duties for any department within the business, which may be requested by Management, for which training and/or an explanation has been provided and understood.

Requirements

Scientific degree in progress
Working knowledge of cGMPs: 21CFR parts 2010 & 211, knowledge of 21CFR600 – Biologics desirable.
Good personal leadership skills and experience
Good collaboration ability
Credible and confident communicator (written and verbal)
Customer focused
Strong analytical and problem-solving ability
Good project management skills
Hands-on approach, with a ‘can do’ attitude
Ability to prioritize, demonstrating good time management skills
Good attention to detail, with the ability to work accurately in a busy and demanding environment
Self-motivated, with the ability to work proactively using own initiative
Committed to learning and development

Nice To Haves

Preferred experience working with an ERP system, such as SAP, and eQMS systems such as Trackwise or Veeva.
Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook)

Responsibilities

Supports QA material inspection and QA Manufacturing activities
Supports logbook and documentation reviews
Supports material inspection activities
Supports document reviews
Supports material complaint support
Supports shop floor observations
Works to support QA Key Performance Indicators (KPIs)
Creates and/or reviews SOPs need to support the business
Supports QA related tasks as assigned by QA Management
Ensuring all activities are performed in accordance with GMPs, SOPs and Health and Safety policies
Gowns into classified areas to observe manufacturing operations in drug substance and drug product manufacturing
Performs facility GEMBAs Redline procedures and GMP documentation for future revision and process improvement initiatives
Supports Warehouse and Material Release QA with material inspection against approved specifications
Supports specification review
Reviews GMP documentation for compliance with site procedures
Generates KPI metrics for department, as needed
Supports Quality Assurance activities to ensure compliance with FDA/EU regulations
Supports QA compliance of departmental SOPs (writing and/or revising), ensuring regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially
Awareness of USP/EP, ICH Guidelines, QC methodology updates to ensure compliance with current testing and specifications
Ensuring appropriate escalation and follow up for non-conformities within GMP areas
Ensuring that the Quality department meets or improves key performance indicators (KPIs)
Undertaking any other duties for any department within the business, which may be requested by Management, for which training and/or an explanation has been provided and understood