COMMISSIONING AND QUALIFICATIONS/COMPUTER SYSTEMS VALIDATION

Role will be ONSITE 100% in Wilson, NC

• Neat would be a huge plus
• MUST HAVE VALIDATION EXPERIENCE, IT IS REQUIRED

Top 3 Skills:

• Experience with Validation
• Be comfortable with working in fast paced environment
• Must have experience performing and approving validation equipment

COMMISSIONING AND QUALIFICATIONS/COMPUTER SYSTEMS VALIDATION (1 of 2 roles)

The purpose of this document is to outline the job description of the QA Specialist, C& Q at client in Wilson, North Carolina.

Essential Job Duties and Responsibilities

This position is responsible for ensuring compliance with regulatory requirements and company policies following current Good Manufacturing Practices, client Policies and internal procedures through the following duties and responsibilities:

• Ensure the site validation program has been developed and maintained in compliance with all regulatory and corporate requirements and Master Plans.
• Works with the applicable qualification teams representing Quality Assurance in the requirement, design review, construction, qualification and leveraging documentation strategies, cleaning development/validation and implementation of project. 
• Review and approve commissioning and qualification documentation, including URS (User Requirements Specifications), IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) protocols and reports, SOP’s, Work Instructions and any other technical document.
• Review and approves validation protocols and reports (analytical, cleaning, process, etc.)
• Provide quality oversight for C&Q/CSV and validation execution activities to ensure compliance with GMP, FDA, EMA, and other regulatory requirements.
• Support the development and implementation of C&Q and validation plans, ensuring alignment with project timelines and deliverables.
• Perform QA reviews of system impact assessments and categorization of equipment and utilities.
• Ensure compliance with company quality standards, including SOPs, work instructions, and quality policies.

Additional Job Duties and Responsibilities:

• Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the client Standards. 
• Partners with other Departments to ensure that compliance systems are implemented in an efficient manner. 
• Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
• Carries out tasks related to the administration of site nonconformance management, change control and training systems and its applicable Electronic Tracking System (ETS).  

Minimum Qualification

• Bachelor's degree in a scientific or engineering discipline is required.
• Two to four (2-4) years of experience working within the biotherapeutic and/or pharmaceutical industry and knowledge in compliance of commissioning, qualification and validation of GMP processes and systems such as Utilities (water for injection, clean steam, process gases, HVAC, SIP/CIP), fridges, freezers, LAF, BSC units, autoclaves and isolators – as well as Process Equipment – Bioreactors, UF/DF, centrifuge, Chromatography systems. 
• 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) and cleaning/process validation.