Quality Assurance Specialist - Biotech

Posted 26 March 2023
Salary Competitive
LocationMassachusetts
Job type Full Time
Discipline Large Molecule
Contact NameJarel Jack

Job description

​Mantell Associates is exclusively partnered with a rapidly growing biotech, specialising in the biologics space.​ This organisation has seen enormous growth over the past two years and are now hiring in their Quality department.

Are you passionate about biologics and looking to join an innovative organisation with endless growth opportunities?

Quality Assurance Specialist Responsibilities:

  • Create, review, and approve documents including standard operating procedures

  • Provide metrics reporting and status updates to Quality management relating to the facility (PD lab, GMP Facility and QC)

  • Management of all documents, manual and electronic documents using Master Control

  • Provide daily QA support for general operation activities, calibration status and preventive maintenance status of equipment and system in PD and QC laboratory and GMP Facility

  • Support continuous improvement and oversight of Quality management System

Quality Assurance Specialist Requirements:

  • Minimum of bachelor’s degree in Life Science

  • 3-5 Years of relevant GMP experience in Pharma/Biotech company, working within quality system and regulated GMP environment

  • Knowledge of cGMP/ ICH/FDA/EU regulations and guidance

  • Proficient in using Microsoft applications (MS word, MS Excel, MS power point)

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting organisation. For more information on this role, please contact Jarel Jack on +44 203 854 7720 or jarel.jack@mantellassociates.com.