# Quality Assurance and Control

**Company**: Pfizer
**Location**: Ohio - Franklin
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Salary**: $68,600.00 to $114,300.00
**Category**: Other
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/United-States---Ohio---Franklin/Validation-and-Compliance-Specialist--GMP-Pharma-Industry_4966132-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/job/quality-assurance-and-control-c1218a9a-90a/

## Description

At Pfizer, you will contribute to the delivery of safe and effective products to patients through your role in quality assurance and control.

**Job Overview** In this role, you will author, review, and approve validation master plans, protocols, and reports to ensure compliance with company standards and regulatory requirements.

**Key Responsibilities**

- Perform various validation activities in compliance with Good Manufacturing Practices (GMP) and Validation Master Plan (VMP) requirements.

- Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.

- Manage routine Quality systems such as Supplier Quality Management, Change Control, Quality Risk Management, Documentation, and Investigations, Annual Product Review, and coordinate testing with functional groups.

- Maintain the Site Validation Master Plan and support validation as a Subject Matter Expert during customer and regulatory audits.

- Support regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations.

**Requirements**

- High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BS with at least 2+ years of experience in the pharmaceutical industry.

- Proven expertise in Good Manufacturing Practices.

- Strong working knowledge of various quality systems and processes.

- Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System.

- Excellent verbal and written communication skills.

- Ability to work independently and in a team environment.

**Preferred Qualifications**

- Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems.

- Experience with quality management systems like Veeva and Kneat.

- Strong analytical and problem-solving skills.

- Strong organizational and time management skills.

- Ability to mentor and guide other colleagues.

- Experience in regulatory audits and compliance.

- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot.

- Technical writing skills.

**Physical and Mental Requirements**

- Ability to perform mathematical calculations and complex data analysis.

- Sitting, lifting, standing, and bending.

**Work Schedule and Travel**

- Minimal travel requirements (less than 5%).

- Position requires regular onsite attendance; this position cannot be performed on a remote/telecommute basis.

**Compensation and Benefits**

- The annual base salary for this position ranges from $68,600.00 to $114,300.00.

- Eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary.

- Comprehensive and generous benefits and programs, including a 401(k) plan with Pfizer Matching Contributions, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits.

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## Skills

### Required
- Good Manufacturing Practices
- Quality Systems
- Validation Master Plan
- Supplier Quality Management
- Change Control
- Quality Risk Management
- Documentation
- Investigations

### Nice to have
- Validation/Qualification of Pharmaceutical Processes
- Quality Management Systems
- Analytical and Problem-Solving Skills
- Organizational and Time Management Skills
- Mentoring and Guiding
- Regulatory Audits and Compliance
- AI Tools
- Technical Writing

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Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/United-States---Ohio---Franklin/Validation-and-Compliance-Specialist--GMP-Pharma-Industry_4966132-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)