REQUIRED SKILLS.

· 3 years of experience

· Corrective actions, Microsoft Office, Scheduling, Investigating, Continuous Quality Improvement, Good Manufacturing Practices, Independent work, Supplier audits, Manufacturing processes

· Previous relevant experience in quality assurance within a medical device, pharmaceutical, biotechnology, CRO, and/or healthcare setting required.

· Experience in design and development of quality plans and audit plans preferred.

· Demonstrated analytical, negotiation, documentation, meeting management, and leadership skills are required.

· Demonstrated knowledge of quality assurance processes including, but not limited to, planning and conduct of site and vendor audits, , Good Documentation Practices (GDP), and Quality Management Systems (QMS) is required.

· Demonstrated ability to effectively interact with and collaborate at all levels in the organization and with external stakeholders, including effective interfaces at the senior management level.

· Strong interpersonal, verbal, and written communication skills.

· Ability to form strong and constructive internal as well as external professional relationships.

· Detail oriented, excellent organizational and management skills.

· Must have a demonstrated core understanding of medical terminology and activities in relation to execution of a development plan.

· Thorough knowledge of FDA guidelines and regulations.

Job Type: Contract

Pay: $40.00 - $45.00 per hour

Expected hours: 40 per week

Experience level:

• 3 years
• 4 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person
• Office

Experience:

• Manufacturing Industries: 2 years (Required)
• FDA regulations: 2 years (Required)
• Good Documentation Practices (GDP): 2 years (Required)
• Quality Management Systems (QMS): 2 years (Required)

Work Location: In person