External Quality Assurance Associate

Proclinical is currently recruiting for an External Quality Assurance Associate with a biotechnology company located in Cambridge, MA. This person is responsible for managing the quality interface with packaging and testing partners for clinical small and/or large molecules, early to late phase for finished drug products.

Job Responsibilities:

• Ensure efficient and effective use of time to support priorities and drive for results
• Oversee quality aspects of GMP activities for clinical product packaged, stored, and distributed, through CMO network. Activities include product disposition, quality support packaging operations, exceptions management, change control, risk management, technology transfer and validation
• Provide Quality expertise to influence tactical decisions needed to package and disposition product in a compliant manner to GMPs
• Support initiatives to improve systems/processes in Global Quality with a goal compliance, efficiency and standardization
• Perform risk assessments in response to product / quality system failures, investigations and regulatory inspections
• Perform tasks and makes decision consistent with cGMPs, GDPs and quality governance
• Collect and perform trend analysis for KPIs
• Primary quality contact for onboarding new clinical assets, product / process transfer, scaleup / validations, product disposition, exceptions (deviation, CAPA), change control and risk management.
• Lead and/or support continuous improvement initiatives related to QMS and procedures for CMO and partner oversight. This person will be the primary quality contact for onboarding and CMO oversight.
• Collaborate with internal and external functions such as External Manufacturing Operations, Clinical Supply Chain, Label Development, Planning & Logistics, Regulatory Affairs, Product Development Quality and Technical Development to ensure compliance with cGMP regulations and QMS.
• Additional duties as assigned

Skills and Requirements:

• Strong knowledge in quality operations and in the application of phase appropriate, risk-based quality principles.
• Ability to develop strong relationships with internal and external counterparts
• Possess effective interpersonal
• Strong verbal and written communications skills
• Collaborative spirit
• Ability to think outside of the box to influence and drive continuous improvement efforts
• Comfortable working in a fast-paced environment with minimal direction
• Ability to deal with ambiguity and changing priorities.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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