Quality Assurance Specialist II - GMP & CAPA Lead

Sentry BioPharma Services, Inc.; Edinburgh (IN); Sur place; USD 65 000 - 90 000; Plein temps

Résumé du poste

Sentry BioPharma Services, Inc. is seeking a detail-oriented Quality Assurance Specialist II to maintain top quality and compliance across our operations.

You will support the Quality Management System, ensure cGMP adherence, and drive continuous improvement in manufacturing, validation, maintenance, and laboratory activities. The role requires strong documentation skills, CAPA leadership, and the ability to work both independently and with teams in a fast-paced environment.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, or related field.
• Minimum 2-4 years of QA experience in a regulated environment (pharmaceutical/biotech preferred).
• Proficient with MS Office, web browsers, barcoding systems; quick to learn new software.
• Strong knowledge of cGMP, quality systems, and validation processes.
• Experience authoring, reviewing, and approving quality docs.
• Excellent organizational skills and ability to manage multiple projects.

Responsabilités

• Independently author, revise, review, and approve SOPs, COPs, policies, and training materials.
• Author, review, and approve GMP/non-GMP records including maintenance and facility docs.
• Lead CAPA initiatives: authoring, tracking, and verifying effectiveness.
• Track and drive completion of QA activities within the QMS per cGMP and standards.
• Provide support and recommendations on compliance of operational, validation, maintenance, and lab tasks.
• Ensure timely completion of quality activity and escape issue investigations.

Connaissances

Detail-oriented

Strong communication skills

Independent and collaborative

Proactive

Formation

Bachelor’s degree in Life Sciences or related field

Outils

Microsoft Word

Microsoft Excel

Microsoft Outlook

eQMS

Description du poste

Sentry BioPharma Services, Inc. is seeking a detail-oriented Quality Assurance Specialist II to maintain top quality and compliance across our operations.

You will support the Quality Management System, ensure cGMP adherence, and drive continuous improvement in manufacturing, validation, maintenance, and laboratory activities. The role requires strong documentation skills, CAPA leadership, and the ability to work both independently and with teams in a fast-paced environment.