Quality Assurance Specialist II - CAPA & Compliance Lead

Sentry BioPharma; Edinburgh (IN); On-site; USD 70,000 - 95,000; Full time

Job summary

Sentry BioPharma is seeking a detail-oriented Quality Assurance Specialist II to join our team. This role supports the Quality Management System, ensures cGMP compliance, and contributes to validation, maintenance, and laboratory processes.

You will author and review SOPs, COPs, policies, and training materials; manage CAPA activities; track quality tasks in the QMS; and help elevate issues to maintain high standards and continuous improvement.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, or a related field.
• 2-4 years of experience in Quality Assurance within a regulated environment (pharma/biotech preferred).
• Proficient in Microsoft Office; quick to learn new software and barcoding systems.
• Strong knowledge of cGMP regulations, quality systems, and validation processes.
• Proven ability to author, review, and approve quality documents and records.
• Excellent organizational and multitasking abilities; strong written and verbal communication.
• Detail-oriented with a focus on accuracy and compliance.
• Ability to work independently and collaboratively within a team.

Responsibilities

• Independently author, revise, review, and approve SOPs, COPs, policies, and training materials.
• Author, review, and approve GMP and non-GMP records, including maintenance and facility documentation.
• Lead CAPA initiatives: author, track, and verify effectiveness.
• Track and drive completion of QA tasks within the QMS per cGMP and company standards.
• Provide guidance on compliance of operational, validation, maintenance, and lab tasks.
• Ensure timely completion of quality activities and elevate issues to maintain compliance.

Skills

Microsoft Office

cGMP knowledge

Quality documentation

Project management

Communication

Detail orientation

Independent and collaborative work

Education

Bachelor’s degree in Life Sciences/Pharmacy/related field

Tools

eQMS

Job description

Sentry BioPharma is seeking a detail-oriented Quality Assurance Specialist II to join our team. This role supports the Quality Management System, ensures cGMP compliance, and contributes to validation, maintenance, and laboratory processes.

You will author and review SOPs, COPs, policies, and training materials; manage CAPA activities; track quality tasks in the QMS; and help elevate issues to maintain high standards and continuous improvement.