Quality Compliance Specialist

We are seeking an experienced Quality Specialist – Commissioning & Qualification (C&Q) to support quality assurance, validation, and compliance activities within a biotherapeutic/pharmaceutical manufacturing environment. This role will provide QA oversight for commissioning, qualification, validation, and related quality systems while collaborating closely with Engineering, Validation, Manufacturing, MSAT, QC, and other cross-functional teams.

Responsibilities:

• Ensure the site validation program is developed and maintained in compliance with regulatory, corporate, and site requirements.
• Represent Quality Assurance throughout requirement development, design review, construction, commissioning, qualification, and project implementation activities.
• Review and approve commissioning and qualification documentation, including URS, FAT, SAT, IQ, OQ, and PQ protocols and reports, SOPs, work instructions, and other technical documents.
• Review and approve validation protocols and reports related to analytical, cleaning, process, and other validation activities.
• Provide QA oversight of C&Q, CSV, and validation execution to ensure compliance with GMP and applicable FDA, EMA, and other regulatory requirements.
• Support development and implementation of C&Q and validation plans, ensuring alignment with project timelines and deliverables.
• Perform QA reviews of system impact assessments and equipment and utility categorization.
• Ensure compliance with company quality standards, SOPs, work instructions, and quality policies.
• Serve as the QA point of contact for deviations, CAPAs, and change controls related to C&Q and validation activities.
• Provide recommendations for process improvements to enhance compliance and efficiency.
• Review and approve Technology Transfer documentation to ensure regulatory and pharmaceutical requirements are met.
• Collaborate with Engineering, Validation, Manufacturing, Operations, Maintenance, MSAT, QC, and other cross-functional teams to address quality and compliance issues.
• Support quality systems and compliance activities, including nonconformance management, change control, training systems, and electronic tracking systems.
• Develop and implement processes, procedures, forms, work instructions, and tools supporting site compliance systems.
• Review documentation related to regulatory submissions, SOPs, and quality management systems for accuracy and compliance.

Minimum Qualifications:

• Bachelor’s Degree in a scientific or engineering discipline.
• 2–4 years of experience within the biotherapeutic and/or pharmaceutical industry.
• Experience with GMP commissioning, qualification, and validation of processes, systems, utilities, and/or equipment.
• Strong understanding of cGMP, FDA, EMA, ICH guidelines, and applicable industry standards.
• Experience with the qualification/validation lifecycle, including URS, FAT, SAT, IQ, OQ, and PQ.
• Knowledge of cleaning and process validation.
• Familiarity with GAMP 5, ASTM E2500, and validation lifecycle principles.
• Understanding of risk-based approaches to commissioning and qualification/validation.
• Strong technical writing skills for validation and quality documentation.
• Strong communication and interpersonal skills for cross-functional collaboration.

Required Skills:

• C&Q / CQV
• GMP Validation & Qualification
• URS / FAT / SAT / IQ / OQ / PQ
• Quality Systems – Deviations, CAPA & Change Control
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