<span>Quality Assurance, C&amp;Q Specialist</span>

$91,000 - $147,200/Yr

Johnson & Johnson - Wilson, NC

Full-time - Mid Level

Wilson, NC

5,001-10,000 employees

Chemical Manufacturing

About the position

The Quality Assurance, C&Q (Commissioning & Qualifications) Specialist at Johnson & Johnson will play a crucial role in ensuring compliance with regulatory requirements and company policies during the commissioning, qualification, and validation activities for equipment, utilities, and facilities. This position supports both the project design phase in the Greater Philadelphia region and the operational start-up of a new manufacturing facility in Wilson, North Carolina. The specialist will be responsible for maintaining high standards of quality throughout the organization, contributing to the development of life-saving therapies, and ensuring adherence to Good Manufacturing Practices (GMP).

Responsibilities

• Ensure the site validation program complies with all regulatory and corporate requirements.
• Work with qualification teams to represent Quality Assurance in design reviews and construction qualifications.
• Review and approve commissioning and qualification documentation, including URS, IQ, OQ, and PQ protocols.
• Provide quality oversight for C&Q and validation execution activities to ensure compliance with GMP and regulatory requirements.
• Support the development and implementation of C&Q and validation plans aligned with project timelines.
• Participate in risk assessments to define qualification/validation requirements.
• Perform QA reviews of system impact assessments and equipment categorization.
• Act as the QA point of contact for deviations, CAPAs, and change controls related to C&Q activities.
• Provide recommendations for process improvements in C&Q and validation activities.
• Collaborate with cross-functional teams to address quality issues.

Requirements

• Bachelor's degree in a scientific or engineering discipline.
• Minimum of 4 years of experience in the biological and/or pharmaceutical industry.
• Strong understanding of cGMP, FDA, EMA, ICH guidelines, and ISPE Baseline Guides.
• Hands-on experience with qualification/validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ).
• Familiarity with ISPE guidelines, including GAMP 5 and validation lifecycle principles.
• Strong understanding of risk-based approaches to commissioning and qualification/validation.
• Proficiency in technical writing for validation and quality documents.
• Strong communication and interpersonal skills for cross-functional collaboration.
• Proven expertise as a Subject Matter Expert in C&Q for regulated industries.
• Proficiency in risk management methodologies such as FMEA and HACCP.

Nice-to-haves

• Knowledge of utilities (water for injection, clean steam, process gases, HVAC, SIP/CIP).
• Experience in development/evolution of C&Q strategies and/or start-up experience.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• Short- and long-term disability
• Business accident insurance
• Group legal insurance
• 401(k) retirement plan
• Vacation time up to 120 hours per year
• Sick time up to 40 hours per year
• Holiday pay including Floating Holidays up to 13 days per year
• Work, Personal and Family Time up to 40 hours per year