Quality Associate

3 weeks ago


Worcester, United States Synectics Inc Full time
Job DescriptionJob Description

Description:

  • The Quality Associate supports the Quality Function that they are responsible for within Operations. This could include: Incoming Quality Assurance of drugs and packaging materials, Manufacturing Quality Assurance, Validation, Quality Engineering, Training and Regulatory Compliance.

  • Expectations that the Quality Associate will maintain high quality levels on all aspects of their job while achieving high levels of efficiency.

  • Responsible for various aspects of quality assurance and quality control related to their functional area.

  • Ensures that product within the plant is consistently manufactured in conformance with company Quality System requirements and all applicable regulatory requirements.

  • Support troubleshooting and resolution of quality compliance issues.

  • Communicates with Management for Quality Management Review, Quality Initiatives, etc.

  • Responsible for quality decisions related to their functional area to ensure compliance with company Quality Systems and cGMPs.

Qualifications:

  • Bachelor's Degree with 2+ years of combined experience in Manufacturing, QA, QC, R&D in pharmaceutical or biologics industry

  • 1+ years within a manufacturing facility

  • Must be familiar with use of electronic document management and laboratory information management.

  • Must also be familiar with Quality Systems as well as cGMP and other regulatory requirements.

  • Strong communication skills, both oral and written

  • Whether it is through manufacturing or quality control, a certain level of quality experience is necessary.

  • Some form of review experience: data or record review

  • Bonus: some work with investigations

  • Bonus: experience with document revisions

  • Bonus: review of GMP commercial batch records



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