Quality Assurance Senior Specialist / Manager for GMP – Steriles QA - Varied & broad-based role ** Growing Biotech, own GMP site ** Nr Bedford, MA

Reference: TM10589R2

Expiry Date: 19-10-2022

Categories Biotech, Clinical Research, Healthcare

Salary: On Application

Job Type: Full Time

Middlesex County
United States

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Job Description

About my Client

Our MA based client is a fast growing biotechnology company focused on delivering transformational therapies for patients with serious, genetically defined diseases.  This R&D biotech organization have a proprietary chemistry platform that enables the production of Oligonucleotides that precisely target the underlying cause of rare diseases and have a work culture that is thoughtful, involving, fun and dynamic. 

This an innovative R&D organization with a very strong future, and they already have their own labs, their own GMP site for Oligo’s and are building the platform, not doing everything virtually!

My team and I are recruiting for a number of different teams in their established and growing Quality Assurance  teams that supports their GMP Manufacturing site near Bedford, Massachusetts.

About The Role

This is a newly created role for a Quality Assurance Senior Specialist / Manager (depending your experiences) responsible for providing Quality Assurance support to and review of batch documentation from Manufacturing, Quality Control, Process Development, Supply Chain for clinical manufacturing and testing initially starting with Drug Substance, and as you develop, then DP / Sterile forms for IMPs.

This is a role with lots of responsibility, and lots of opportunity to learn from the line manager, who is keen to develop this position, and covers many activities from reviewing and approving GMP documentation to performing activities related to quality events to Coaching & Training QA and other functional teams.

There is real flexibility around working hours and home working a few days a week and the expectation is this role could be a stepping stone to other opportunities in Quality Assurance.  The company would also consider 80% working. On offer is a good salary and bonus, with the opportunity to become heavily involved in how the QA systems and processes will grow and develop as the company continues to grow quickly in size and stature.

We are looking for someone with a Bachelor’s degree in Chemistry with experience of Quality Assurance in a GMP environment to take care of the following:

  • Review batch records, testing records, Certificates of analysis, logs, and other documentation to ensure compliance and adequate documentation, in support of drug substance and drug product disposition
  • Review stability protocols and reports
  • Write, review and approve GMP documentation (SOPs, protocols, technical reports, specifications, etc.)
  • Perform activities for raw materials including but not limited to review and disposition of materials, creating/updating specifications.
  • Assist in the implementation of GXP quality standards, policies, and procedures.
  • Perform activities related to quality events such as out of specification investigations, change controls, deviations, and CAPAs.
  • Support equipment validation, maintenance and calibration activities including document generation, review, and approval.
  • Participate in internal audits and ensure that related follow-up activities are performed.
  • Coach/Train QA and other functional teams
  • Cross train on other QA functions


To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore, for this role by email to theo@advtalent.com or if you would like more information on the role, on US 908-348-6714 daily, till 7 PM Eastern Time. I will support you throughout the interview and on-boarding experience.

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