GSK is currently looking for an Associate QA Documentation Specialist in Cambridge, MA. This position provides the opportunity to work directly with Manufacturing, Supply Chain, Warehouse and QC EM staff for continuous improvements of the Quality Management Systems with focus on Document Management and Control.

The ideal candidate will possess experience in GMP Document Control at a Manufacturing site with working knowledge of cGMP regulations. This on-site position is for M-F 11am to 7pm shift.

Key Responsibilities:

• Responsible for the organization and management of cGXP documents and records in QA Document Control. Duties may include:
  • Master batch record issuance, tracking, reconciliation, scanning and archival to support site manufacturing operations.
  • Logbook issuance, tracking, reconciliation, and archival for the site.
  • Site Administration for Veeva QualityDocs.
  • Management and coaching of document owners on using QA documentation systems.
  • Maintenance of KPIs for Document Control
  • Participation in QA documentation continuous improvement projects.
  • Collaboration cross-site and cross-functionally to identify efficiencies.
  • Maintenance of audit readiness for Document Control.

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• HS Diploma and a minimum 3 years of cGXP/cGMP documentation experience OR Associates Degree or Bachelor's Degree and 1 years of cGXP/cGMP documentation experience.

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Able to respond to changing priorities and expectations with a composed demeanor and foster effective cross-functional relationships.
• Excellent communication, writing and presentation skills for interfacing with internal and external organizations.
• Strong collaboration and team skills
• Able to think through the process and accurately apply and adapt GSK and regulatory standards.
• Helpful to understand the QA function in a start-up entity and ability to make decisions on go/no go criteria.
• Able to work effectively within a variety of situations and adapt enthusiastically to changes in job demands.
• Pursue tasks with energy, drive, and initiative; even in a fast-paced environment.
• Comfortable in a results-driven, highly accountable environment where you can make an impact.
• Builds productive working relationships across key groups.
• Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure.

#LI-GSK

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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