Quality Specialist

Kelly; Wilson (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

Kelly, in partnership with Johnson & Johnson, seeks a Quality Specialist to ensure regulatory and company policy compliance across cGMP, FDA/EMA guidelines, and internal procedures. The role covers QA oversight of commissioning/qualification, validation lifecycle, and technical documentation in a fast-paced manufacturing environment.

Responsibilities include developing validation plans, reviewing URS/IQ/OQ/PQ docs, and supporting deviations, CAPAs, and change controls.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline is required.
• Minimum of two years in a regulated industry.
• At least one year in Quality Assurance within biotherapeutic/pharma.
• Knowledge of GMP, FDA/EMA/ICH guidance and ISPE Baseline Guides.
• Hands-on qualification and validation lifecycle (URS, FAT, SAT, IQ, OQ, PQ).
• Experience with cleaning and process validation.
• Strong technical writing for validation and quality documents.
• Ability to collaborate with cross-functional teams and handle multiple priorities.

Responsibilities

• Develop and maintain the site validation program in line with regulatory and corporate requirements.
• Collaborate with qualification teams across design, construction, qualification and project implementation phases.
• Review and approve commissioning/qualification docs and SOPs.
• Provide QA oversight of C&Q, CSV and validation activities for compliance.
• Support development of C&Q/validation plans aligned to timelines.
• Review system impact assessments and understand equipment categorization.
• Ensure adherence to quality standards and change controls related to validation.

Skills

Regulated industry experience

Quality Assurance

cGMP knowledge

Technical writing

Cross-functional collaboration

Independent work

Multitasking

Problem solving

Education

Bachelor's degree in a scientific or engineering discipline

Tools

GAMP 5

ISPE Baseline Guides

URS/FAT/SAT/IQ/OQ/PQ processes

Job description

Kelly, in partnership with Johnson & Johnson, is hiring a Quality Specialist

Description:

This position is responsible for ensuring compliance with regulatory requirements and company policies in accordance with current Good Manufacturing Practices (cGMP), Johnson & Johnson policies, and internal procedures.

Key Responsibilities include, but are not limited to:

• Ensure that the site validation program is developed and maintained in compliance with all applicable regulatory and corporate requirements and master plans.
• Work with applicable qualification teams, representing Quality Assurance throughout the requirements definition, design review, construction, qualification, and project implementation phases.
• Support documentation strategies, cleaning development and validation, and the implementation of related projects.
• Review and approve commissioning and qualification documentation, including User Requirements Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports; Standard Operating Procedures (SOPs); work instructions; and other technical documents.
• Review and approve validation protocols and reports, including analytical, cleaning, and process validation documentation.
• Provide quality oversight of commissioning and qualification (C&Q), Computerized System Validation (CSV), and validation execution activities to ensure compliance with cGMP, FDA, EMA, and other applicable regulatory requirements.
• Support the development and implementation of C&Q and validation plans, ensuring alignment with project timelines, milestones, and deliverables.
• Perform Quality Assurance reviews of system impact assessments and the categorization of equipment and utilities.
• Ensure compliance with company quality standards, including SOPs, work instructions, and quality policies.
• Act as the Quality Assurance point of contact for deviations, Corrective and Preventive Actions (CAPAs), and change controls related to C&Q and validation activities.
• Provide recommendations for process improvements to enhance compliance, consistency, and efficiency in C&Q and validation activities.
• Review and approve Technology Transfer documents to ensure that they meet applicable regulatory and Johnson & Johnson requirements.
• Collaborate with cross-functional teams, including Operations, Engineering and Maintenance, Manufacturing, Manufacturing Science and Technology (MSAT), Quality Control (QC), and Validation, to address quality issues.
• Provide support and direction to departments regarding specific quality-system elements to ensure that business, quality, and compliance goals are met in accordance with Johnson & Johnson standards.
• Partner with other departments to ensure that compliance systems are implemented efficiently and effectively.
• Develop and implement processes, procedures, forms, work instructions, and tools related to compliance systems at the site.
• Support the administration of site nonconformance management, change control, and training systems, including the applicable Electronic Tracking System (ETS).
• Support documentation review through the evaluation and approval of documents related to regulatory submissions, SOPs, and quality management systems to ensure accuracy and compliance, as required.

Required Skills and Experience:

• Bachelor’s degree in a scientific or engineering discipline is required.
• Minimum of two years of experience working in a regulated industry.
• At least one year of experience in Quality Assurance within the biotherapeutic and/or pharmaceutical industry.
• Knowledge of commissioning, qualification, and validation requirements for GMP processes and systems, including utilities such as Water for Injection (WFI), clean steam, process gases, HVAC, and SIP/CIP systems.
• Experience with process equipment such as refrigerators, freezers, Laminar Airflow (LAF) units, Biological Safety Cabinets (BSCs), autoclaves, isolators, bioreactors, ultrafiltration/diafiltration (UF/DF) systems, centrifuges, and chromatography systems.
• Strong understanding of cGMP requirements and applicable FDA, EMA, and ICH guidance, as well as ISPE Baseline Guides.
• Hands-on experience with the qualification and validation lifecycle, including URS, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), IQ, OQ, and PQ.
• Experience with cleaning and process validation.
• Familiarity with ISPE guidelines, including GAMP 5, ASTM E2500, and validation lifecycle principles.
• Strong understanding of risk-based approaches to commissioning, qualification, and validation.
• Proficiency in technical writing for validation and quality documents.
• Understanding of antibody structure and function, as well as biologic therapeutic modalities.
• High level of integrity and a demonstrated commitment to ethical conduct and compliance with regulatory requirements.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Proven ability to manage multiple priorities and work independently with minimal supervision.
• Detail-oriented approach, with the ability to identify opportunities for process improvement.
• Proven ability to prioritize tasks and meet deadlines in a dynamic manufacturing environment.
• Ability to build and maintain strong, positive working relationships.
• Ability to work effectively in a team environment and interact with employees at all levels of the organization.

Preferred Skills and Experience:

• Experience in the biotherapeutic and/or pharmaceutical industry.