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Mersana Therapeutics
Cambridge, Massachusetts, United States
30+ days ago
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Mersana Therapeutics
Cambridge, Massachusetts, United States
30+ days ago

Description

Mersana Therapeutics has an exciting new opportunity to join our growing organization as a Senior Specialist, Document Control & Training.

What’s in it for you?


In this role, you will make quality decisions that will influence the success and progression of Mersana’s clinical pipeline while also having the opportunity to promote and advance the quality culture at Mersana.  In addition to working with an awesome team, you will have the opportunity to create an influential and collaborative relationship for Quality across Mersana. 

You will:

  • Be accountable for the Document Control and Training activities for the company
  • Own the document control activities that is maintained in the Veeva Quality Docs system. Also, performing the System Administrator function for the system.
  • Work with and collaborate with internal partners in document archiving of Mersana documents
  • Build a Training program that will expand with the company as it grows
  • Be a part of a growing company you will have the ability build processes that will drive innovation, teamwork and efficiency within the organization

To be successful, you must have broad experience in a Quality Assurance role supporting; GLP, GCP, GMP and enjoy working in a fast-paced GxP environment. This role reports directly to the Head of Quality. Together, you will promote a culture of quality and operational excellence.

How do you know if you’re the right fit?


You may be the right fit if you are interested in building a phase appropriate quality management system, work as a team with other colleagues to advance the quality culture through mentoring, participation in cross-functional teams and building processes that enable the advancement of Mersana’s technology and clinical pipeline. This is an influential role for Mersana and the candidate must bring deep quality knowledge (GLP, GCP, GMP) to the role along with strong collaboration and communication skills.  Some key areas of responsibility are noted below:

  • Document Control experience utilizing electronic systems (Veeva) or other document control systems as appropriate.
  • Experience running a Training program providing group/department training metrics.
  • Support the quality organization in developing, implementing and maintaining Quality Systems.
  • Support compliant quality systems, including but not limited to document control, change control, investigations, deviations, CAPA, and product/customer complaints. Write and/or review associated SOPs, forms, and templates.
  • Manage competing priorities to meet departmental and organizational targets and timelines
  • Promote a culture of quality and operational excellence

The other stuff


This role is best suited for a quality professional who has 
the desire and ability to work in a fast-paced, start-up environment and has a BA/BS in a scientific field of study with at least 3-5 years of experience in quality assurance in Document Control and Training in the biotechnology or pharmaceutical industry with a sound knowledge of the end-to-end drug development processes.  

  • Demonstrated experience with creating and implementing effective cGMP quality systems, inclusive of writing SOPs; product release activities.
  • In depth understanding and application of industry standards and cGMP/international regulations and guidelines
  • Strong collaboration, team-work, organizational skills and attention to detail are a must

Position is eligible for bonus, option awards and benefits including medical, dental and life insurance, 401(k) participation, vacation and paid holidays.

Successful candidate must be authorized to work in the United States.

Mersana Therapeutics, Inc. is an equal opportunity employer.



Job Information

  • Job ID: 62650580
  • Location:
    Cambridge, Massachusetts, United States
  • Position Title: Senior Specialist, Document Control & Training
  • Company Name For Job: Mersana Therapeutics
  • Job Function: Clinical,
    Quality Assurance,
    Quality Control
  • Job Type: Full-Time

Please refer to the company's website or job descriptions to learn more about them.

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