Quality Assurance Specialist

Harbor Clinical; United States; Hybrid; USD 41,328 - 61,992; Part time

Job summary

A certified clinical service firm is seeking a contract QA Specialist in the United States. This role requires a candidate with 2-6 years of experience in QA or manufacturing within life sciences. Responsibilities include supporting quality management systems, assisting with document control, and partnering with manufacturing teams to ensure compliance. The ideal candidate will be organized, adaptable, and possess a solid understanding of GMP. This position offers both part-time and full-time opportunities.

Qualifications

• 2-6 years in manufacturing, operations, or QA within life sciences or related fields.
• Experience with Document Control systems preferred.
• Understanding of GMP and quality fundamentals.

Responsibilities

• Maintain and support QMS activities, especially Document Control.
• Partner with manufacturing teams to ensure quality practices.
• Assist with SOP updates and quality documentation.

Skills

Manufacturing experience

Document Control

Quality Assurance

GMP understanding

Tools

Veeva

Job description

Harbor Clinical, a certified women owned clinical service firm is seeking a contract QA Specialist who has experience with Manufacturing & Document Control. There are two roles with comparable job requirements and qualifications. One is a part time position, averaging 15 to 20 hours per week, and a second one which is up to 40 hours per week. For this second role, the ideal candidate will possess a practical, manufacturing‑savvy, and collaborative, comfortable building structure while also doing the day‑to‑day quality work.

Responsibilities

• Maintain and support QMS activities, especially Document Control and change management.
• Partner with manufacturing teams to ensure quality practices on the floor.
• Assist with SOP updates, workflow improvements, and quality documentation.
• Perform daily QA tasks including document routing, version control, and record maintenance.
• Support audits, deviations, and CAPA activities as needed.
• Contribute to quality strategy while staying involved in tactical work.

Qualifications

• 2–6 years in manufacturing, operations, or QA within life sciences or related fields.
• Experience with Document Control systems; Veeva is a plus, but not required.
• Understanding of GMP and quality fundamentals.
• Ability to balance strategic insight with hands‑on work.
• Organized, adaptable, and eager to learn.