Job Description

We are seeking a detail-oriented and highly experienced Quality Assurance Specialist II or III to join our team in ensuring compliance with regulatory standards and internal quality systems. This role plays a key part in maintaining product quality and integrity, driving continuous improvement, and supporting quality-related activities.

Responsibilities

• Lead executed manufacturing and testing document review and Final Product release.
• Lead and support investigations of deviations, non-conformances, and CAPAs.
• Author Quality related documents (including but not limited to SOPs, forms, plans, protocols and work instructions).
• Provide quality review of documents (including but not limited to SOPs, forms, plans, master batch records, protocols, reports and work instructions).
• Participate in audits and support regulatory inspections.
• Collaborate with cross-functional teams to resolve quality issues.
• Evaluate and approve change controls, risk assessments, and supplier qualifications.
• Provide QA support during product development, tech transfers, and validation activities.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 3-5 or 5–7 years of experience in pharmaceutical QA or a related GMP-regulated environment.
• Strong knowledge of cGMP, ICH guidelines, and applicable FDA regulations.
• Experience with document management systems and quality management software.
• Excellent attention to detail, problem-solving skills, and ability to manage multiple priorities.

Preferred Skills

• Experience in sterile/aseptic manufacturing, biologics, or Cell and Gene Therapies.
• Effective communication and interpersonal skills; team-oriented mindset.

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