MQA Product Release Specialist

US-NY-Melville
ID
2017-3558
# of Openings
1
Category
Quality
Type
Direct Hire

Overview

The candidate for the Manufacturing Quality Assurance Specialist has a robust understanding of applicable regulations and standards and is able to apply company policies, directives, and procedures to ensure compliance by conducting review and approval of quality and production related documentation and procedures in support of internal manufacturing operations. The position advises QA management of compliance issues, conducts quality related activities of diverse scope, and makes decisions and implements associated actions in partnership with the broader team.

Responsibilities

  • Oversee activities during cGMP production operations.
  • Assist in the development of Standard Operating Procedures, Master batch Record in order to maintain quality systems in line with current regulations, company directives, and industry standards.
  • Write Quality Procedures related to production activities.
  • Review manufacturing batch records and logbooks.
  • Monitor and inspect the production facility during product manufacture and notify QA of potential quality issues.
  • Participate in corporate audits and self audits and monitor implementation of CAPAs.
  • Carry out assessment of the event, and manage investigation of Deviation, Incident and complaint.
  • Oversee activities during validation activities of equipment.
  • Participate in training activities to production personnel.
  • Monitor the proper implementation of change control for production activities.

Qualifications

Qualifications:

  • Bachelor's Degree in scientific or technical discipline
  • Three (3) + years’ experience in Quality Assurance operations or systems role, e.g., quality systems (deviation/CAPA, change control), batch record review, auditing
  • Four (4) + years Pharmaceutical I Regulated Industry experience
  • Good organizational skills with high level of attention to detaiL
  • Excellent oral and written communication skills with the ability to interact at all levels both internally and externally


 

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