# Operational Quality Oversight

**Company**: GSK
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Category**: Operations
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---Marietta/Operational-Quality-Specialist_446693?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_d2342a56-881

## Description

You will provide operational quality oversight at a United States manufacturing site. You will work closely with production, laboratories, engineering and quality teams to keep processes compliant, safe, and reliable.

Responsibilities:

- Ensure GMP processes and personnel adhere to current GMP and regulatory requirements

- Maintain shopfloor oversight and be the first line of contact for quality issues

- Provide guidance during GMP activities to detect potential quality issues

- Perform spot-checks of activities across production and laboratory areas

- Review and approve batch records and documentation

- Provide review and approval of deviations and CAPA plans

- Ensure all GMPs, validation, quality, safety and environmental regulations are met

- Coach employees on the importance of following procedures

- Provide on-the-floor quality oversight and detect early quality risks

- Make or recommend disposition decisions and support lot release activities

Basic Qualifications:

- Bachelor’s degree in biology, chemical engineering, life sciences field or equivalent

- 2+ years of experience in regulated industry with strong quality assurance background

- 1+ years of experience with GMP’s, NIH Guidelines, FDA and other regulatory agency compliance requirements

- Experience with validation principles, aseptic processing, quality systems and FDA regulations

Preferred Qualifications:

- Experience in biologics or pharmaceutical manufacturing environments

- Training or experience in root cause analysis methods such as DMAIC

- Familiarity with inspection readiness and regulatory agency expectations

## Skills

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

### Nice to have
- Biologics Manufacturing
- Root Cause Analysis
- Inspection Readiness
- Regulatory Agency Expectations
- DMAIC

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Source: [Apply at gsk.wd5.myworkdayjobs.com](https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---Marietta/Operational-Quality-Specialist_446693?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)