Supplier Quality Specialist

Company Overview

Synergy Bioscience is a startup company that provides medicinal product development support, laboratory testing, and quality compliance consulting services to our partners in the pharmaceutical and medical device industries.

Our mission is to support our clients with their product development and commercialization efforts by providing world?class services in a timely manner without compromising our business confidentiality.

We are looking for a Supplier Quality Management Specialist to help with reviewing a large number of different audit findings related to supplier quality.

Responsibilities

• Analyzes audit reports findings and categorizes them in terms of criticality and determines trends and recommends corrective actions.
• Review the current SOPs, and regulatory requirements, determine if a compliance gas still exists, and determine how it should be addressed.
• Initiation and ownership of NC and CAPA, build proficiency in problem?solving and root?causing activities.
• Participate in the development and improvement of the supplier manufacturing processes for existing and new products.
• Develop an understanding of risk management practices and concepts and become proficient in process risk.
• Support the QMS with QE support. Interpret quality data and non?conformances.
• Perform failure evaluations, determine root cause, and implement corrective action.
• Work with Operations and Manufacturing Engineering on production process flow, PFMEA, and Master Validation Plan.
• Work closely with contract manufacturers on product transfers and process validations, help define in?line inspection points to improve product quality, and author product quality plans as needed.
• Own and manage individual CAPAs. Work with a cross?functional team to investigate root causes and drive corrective actions.
• Support risk management activities. Able to update risk management files and draft Health Hazard Evaluations as needed.
• Review and approve interdepartmental records, documents, and SOPs to ensure conformance with the regulations and guidelines.

Qualifications / Experience

Duration

1 year or more

Location

Remote Work

Type

Consulting on 1099 or C2C.

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