Quality Manufacturing

Boston, MA

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 the company’s 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 company initiatives to improve systems/processes in Global Quality with a goal of 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 company’s quality governance
  • Collect and perform trend analysis for KPIs

 

Requirements

 

  • Minimum of 2 years pharmaceutical manufacturing, packaging, or laboratory experience including at least 5 years in clinical and or commercial quality operations.
  • Experience in quality operations as it relates to unit operations for the manufacture of either one or more of the following modalities: Parenteral, Oral Solid Dosage Form, ASOs.
  • Experience working with third-party GMP vendors.
  • Comprehensive knowledge of GMP and GDP regulations and subsequent applications to pharmaceutical drug manufacturing, and or packaging and distribution.
  • Good understanding of CMO mediated Supply Chain activities including process, technology transfer, and routine operations
  • Experience in contributing to regulatory filings and inspections preferred.

 

 

 

 

Note: Qualified candidates will be contacted within 2 business days of application. If an applicant does not meet the above criteria, we will keep your resume on file for future opportunities and may contact you for further discussion.

Date Posted 5/22/2020
Salary $25.00/hr






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