Senior QA Specialist

WuXi Biologics; Cranbury Township (NJ); On-site; USD 90,000 - 120,000; Full time

Job summary

WuXi Biologics is seeking an experienced Senior QA Specialist I to lead QA training initiatives within our Quality Assurance team. The role involves coordinating cross-functional teams, driving training plans, and ensuring GMP compliance to deliver timely quality outcomes.

Located in Cranbury, NJ, you will report to the Quality Assurance Manager and work with multiple departments to manage training projects and risk. A strong background in life sciences and QA training is required.

Qualifications

• Bachelor's or Master's degree in Life Sciences or related field.
• 3–5 years' experience in QA training or learning and development, preferably in pharma/biotech.
• Familiarity with GMP regulations and project management methodologies.
• Strong communication, problem-solving and organizational skills; experience with QA training tools.

Responsibilities

• Oversee QA training related projects, ensuring timely completion and quality.
• Coordinate cross-functional teams (QC, Regulatory and other departments).
• Develop and execute project plans and timelines related to training.
• Ensure compliance with GMP and regulatory requirements.
• Identify and mitigate project risks and track progress.
• Support audits and related activities as required.

Skills

QA training

Communication

Project management

Education

Bachelor's/Master's in Life Sciences

Tools

MasterControl

Veeva

Up4Growth

ComplianceWire

TrackWise

Job description

Job Summary

We're seeking an experienced QA Senior Specialist to join our Quality Assurance team. The successful candidate will be responsible for leading QA training, facilitating the training methods, and should have great knowledge of training skills, ensuring quality and timely delivery. Coordinate cross-functional teams, manage timelines, and ensure GMP compliance. Drive training coordinators successfully through effective communication and Training risk management.

Job Title: Senior QA Specialist I

Reports to: Quality Assurance Manager

Location: US-CRAN

Key Responsibilities

• Oversee QA training related projects, ensuring timely completion and quality
• Coordinate cross-functional teams (QC, Regulatory and other relevant departments etc.)
• Develop and execute project plans, timelines related to training
• Ensure compliance with GMP, regulatory requirements
• Identify and mitigate project risks, track progress

Support Audits And Other Activities As Required.

Requirements

• Bachelor's/Master's in relevant field (e.g., Life Sciences, Pharmacy)
• 3-5 years in QA training or learning and development, preferably in pharma/biotech
• GMP regulations, project management methodologies
• Strong communication, problem-solving, and organizational skills and Tools such Master control, Veva, Up4growth, Compliance Wire, Trackwise or any training related tools.

WuXi Biologics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability