Quality Assurance Associate Lead

6 days ago


Waltham, Massachusetts, United States Mindlance Full time

Job Description:

We are seeking a highly skilled Quality Assurance Associate II to join our team at Mindlance. In this role, you will be responsible for ensuring the highest quality standards in our manufacturing processes.

Main Responsibilities:

  • Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents to ensure timely initiation of GMP manufacturing activities.
  • Perform QA review of Executed Batch Records to ensure compliance with cGMP regulations.
  • Perform QA review of Quality Records, such as Deviations, CAPAs, OOS, etc., as they occur.
  • Review and approve SOPs, forms, WI, and other document types to ensure adherence to company policies.
  • Provide SAP support for GMID and BOM approval to ensure seamless manufacturing operations.
  • Ensure all requirements stipulated in the CMO Quality Agreements are being met.
  • Review and Approve Analytical related documents, such as Test Methods, Test Method Transfer Plans and Assessments, if needed.
  • Participate in Quality Risk Assessments to identify potential risks and mitigate them.
  • Assist with internal and external audits to ensure compliance with regulatory requirements.
  • Support data analysis and metrics for Quality Council, KPls, and other reportable forums.

Requirements:

  • Bachelor's degree and/or 8+ years of relevant experience in Quality Assurance.
  • Minimum 5 years of experience in Quality Assurance with a strong understanding of cGMP regulations.
  • Excellent written and verbal communication skills with the ability to interact with peers, management, auditors, and consultants.
  • Strong attention to detail, project management skills, and ability to manage multiple priorities with aggressive timelines.
  • Preferred experience with outsourced manufacturing and testing operations.
  • Working knowledge of MS Office products, including Word, Excel, Outlook, PowerPoint, and Project.

Benefits:

  • $85,000 - $110,000 per annum, depending on experience.
  • Comprehensive benefits package, including health insurance, retirement plan, and paid time off.
  • Opportunities for professional growth and development within the company.


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