QA Senior Specialist, Auditor

Location
Cambridge, MA, United States
Posted
Nov 28, 2018
Ref
R-01020
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Title:
QA Senior Specialist, Auditor

Company:
Ipsen Bioscience, Inc.

Job Description:

Position Summary

Under the direction of the Senior Manager of Supplier Quality, the Senior QA Specialist is responsible for review and approval of the vendor and service provider management program with respect to change notification management, handling of non-conforming material issues. Includes drafting and implementing Quality Agreements and CDA's with suppliers and contract organizations. This position in the Quality Assurance group includes oversight of Technical Quality Agreements, Vendor Change Notifications and Non-Conforming Product with external manufacturing and distribution activities as well as the GxP (GMP, GCP, GLP, GCLP) supplier management program.

Responsibilities
  • Oversight of Quality Agreements, Change Notification and Non-Conforming Material, including:
  • Non-conformance handling, change notification management, TSE/BSE statements, and material specification reviews
  • Drafting, review, and management of supplier quality agreements and non-disclosure agreements
  • Coordination of internal information regarding the current & future use of suppliers
  • Performing Audits/re-assessments which includes scheduling, performing, report writing and response review and closure of the audit
  • Making Process improvements as needed
  • Working and collaborating with Global Supplier Quality
  • Creating the yearly Supplier Schedule
  • Manage the Approved Supplier List
  • Performing Gap assessments with local procedures and Global and Corporate Policies
  • Write, review, and manage related Quality Systems
  • Write, reassess, and revise program SOP's as required
  • Train, support, and mentor staff and consultants
  • Serve as a QA representative on teams as needed
  • Assist with additional projects as needed

Qualifications

Education
  • BS degree or higher (preferably in Biology or Chemistry)
  • Auditing certification preferred (ASQ CQA or similar)

Experience
  • 7+ years QA GMP experience in the pharmaceutical/biotechnology industry


IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.