# Quality Unit Business Process Specialist

**Company**: GSK
**Location**: Marietta, Pennsylvania
**Work arrangement**: onsite
**Experience**: mid
**Job type**: full-time
**Category**: Operations
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---Marietta/Quality-Unit-Business-Process-Specialist---Drug-Substance_450326?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
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## Description

Join GSK as a Quality Unit Business Process Specialist supporting drug substance operations at a United States site. You will collaborate daily with manufacturing, quality, IT, and engineering teams to ensure quality processes run smoothly and compliantly.

Responsibilities:

- Provide quality oversight for drug substance-related business processes and systems, ensuring compliance with regulations and internal standards.

- Support investigations, root cause analysis, and corrective and preventive actions related to quality deviations and process issues.

- Facilitate quality impact assessments and risk reviews for process and system changes.

- Train and coach site colleagues on quality processes, documentation practices, and compliance requirements.

Basic Qualifications:

- Bachelor’s degree in life sciences, engineering, quality, or a related technical field.

- Minimum 3 years’ experience in cGMP production, quality control, or quality assurance in a regulated life sciences environment.

- Practical knowledge of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and regulatory compliance.

Preferred Qualifications:

- Experience in pharmaceutical or biologics manufacturing environments, particularly with computerized manufacturing systems.

- Formal training or experience in structured root cause analysis and risk assessment techniques.

- Proven ability to influence and coach colleagues at different levels and from multiple disciplines.

Benefits: GSK offers a comprehensive benefits program, which can be found at GSK US Benefits Summary.

#LI-GSK #GSKCareers

## Skills

### Required
- GxP Regulations
- Lean Management
- Pharmaceutical Regulatory Compliance
- Problem Solving
- Quality Assurance (QA)
- Risk Awareness
- Technical Writing
- Data Integrity
- Digital Fluency
- Influencing Without Authority

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