Quality Assurance Operations (Snr) Specialist *** Join a Growing Biotech offering opportunities for development and growth! *** Lexington, MA

Reference: TMV080622A

Expiry Date: 28-09-2022

Categories Biotech, Manufacturing / Production, R & D

Salary: On Application

Job Type: Full Time

Middlesex County
United States

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Job Description

My client is a biotechnology company focused on delivering transformational therapies for patients with serious, genetically defined diseases. But they are different! They have a chemistry platform that enables them to develop potential medicines to reduce, restore or modulate proteins responsible for genetic diseases.

In the last few years, they have assembled an extremely talented and experienced team, led cutting-edge advancements in potentially disease-modifying treatments and initiated clinical trials in their lead programs. It’s an exciting time of progress, yet there is still much more to accomplish.

As part of their regional and global expansion plans, they are seeking Quality Assurance Specialists and Leaders to join their growing Quality team.

Quality Assurance Operations (Snr) Specialist

This position provides quality oversight to manufacturing and quality operations, including label review, issuance and reconciliation, batch record review and approval. You will also support the quality team with related duties, but the role will continue to grow and expand as you become more comfortable and experienced with the Quality Systems in place. This is an onsite position, with a possibility to work a few days a week from home, but reporting to the manufacturing site in Lexington, MA.

The team is led by an experienced and engaging Head of Quality Assurance, who will look to help you develop your experience and prepare you for a more senior role – Growth and development within this QA department is the norm, its expected and encouraged!

“This is a time of opportunity, to be part of a dynamic environment, to play a significant role at a growing organization, to be a part of a new era of life-changing medicines. You are invited to join a company with the potential to change the landscape of rare diseases.”

On offer here is a competitive base salary, with a yearly bonus, company stock options, and a very competitive overall benefits package.


  • Bachelor’s degree in Biology, Chemistry, or a similar scientific field.
  • Minimum of 3 - 5 years of work experience in a Quality Assurance/Materials organization.
  • Must have experience working in a cGMP environment in the pharmaceutical or biotechnology industry and have strong knowledge of cGMP regulations.
  • Experience with Quality Management Systems.
  • Experience in drug batch record review for sterile products.
  • Some labeling experience is strongly preferred.
  • Experience working collaboratively with CMOs is preferred.
  • Proficient with MS Word, Excel, and Outlook.


To Apply!

To apply for this role, please contact me Theo Moore on US 908-348-6714, alternatively, please send a full CV to me in confidence on Theo@AdvTalent.com and I will reply by return.

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