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Senior QA Project Manager (cGMP – Pharmaceutical – Change Control) JD819684

JD819684

DPS is looking for a Senior Quality Assurance Specialist to work with a BioPharma client in the Boston, MA area. Ideal candidates should have a strong understanding of GMP and have previous experience working within highly regulated pharmaceutical/biotech facilities. This individual will be responsible for owning change controls and working cross-functionally within a capital project environment to manage documentation and impacts associated with changes.

Category:
Quality
Location:
Massachusetts
Years of Experience Req.:
5+
Date Posted:
15/06/2019
Days Remaining:
18
Employment Type:
Full-time
Education Level Req.:
Bachelors

Senior QA Specialist (cGMP – Pharmaceutical – Change Control)              JD819684

Boston, MA

 

Summary:

 

DPS is looking for a Senior Quality Assurance Specialist to work with a BioPharma client in the Boston, MA area. Ideal candidates should have a strong understanding of GMP and have previous experience working within highly regulated pharmaceutical/biotech facilities.

 

This individual will be responsible for owning change controls and working cross-functionally within a capital project environment to manage documentation and impacts associated with changes.

 

Responsibilities:

  • Design, development, implementation and proper execution of Change Control practices across all GxP systems.
  • Works with the documentation and training organiz721987.475345ation to design appropriate training materials in support of Change Control.
  • Create, revise, and update all standards and SOPs in support of Change Control.
  • Work with individual departments as well as cross-functional teams to assist in the management of changes.

 

Qualifications:

  • Bachelors of Science degree in Engineering, Chemistry, Biology or related field.
  • 5+ years’ of GMP-related experience in biopharmaceutical or pharmaceutical manufacturing facilities.
  • Electronic Quality Management implementation and support experience.
  • Demonstrated experience of Change Control.
  • Knowledge of regulatory and industry guidelines and requirements.
  • Knowledge of cGMPs as well as sound quality and regulatory principles consistent with best practices'.
  • Attention to detail required. Ability to read, understand, interpret and apply technical writing and instructions.
  • Good verbal and written communication skills.
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