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Operational QA Advisor at GlaxoSmithKline

Posted in Software 30+ days ago.

This job brought to you by eQuest

Type: Full-Time
Location: King of Prussia, Pennsylvania

Job Description:

Position Title: Operational QA Advisor

Working Location: Pennsylvania

Employment Status: Full time

Required Experience: 2 years

Required Education: Bachelors

Travel Required: 0%

Job Description:

An opportunity has arisen to join External QA in the US as an Advisor. External QA is part of Preclinical Quality Assurance in Global Quality and Compliance that provides QA support to PDS and GSK's third party partners. External QA is a global team based in UK, US & Shanghai.

The role will work closely with and assist all the External QA Managers in their support of the activities ongoing at third parties globally.

The successful candidate will have a critical role in ensuring quality and compliance of Investigational Medicinal Products used worldwide. In addition the job holder will have the opportunity to further develop existing expertise and to gain experience within an R&D environment.

Key responsibilities include:

Review of documentation (batch and analytical records) and recommend release for a range of dosage form batches and finished clinical trial packs of Investigational Medicinal Products in accordance with GMP/GSK requirements.

Assessment of Quality Deviations, customer complaints and vendor complaints and make recommendations for corrective and preventative actions, and follow up on the implementation of those recommendations.

Initiation and maintenance of quality agreements with third party suppliers & contractors

Assist in the collection and compilation of Supplier performance data and metrics

Provide advice and support to business partner areas relating to quality matters and process improvement.


Essential Skills:

• Bachelor’s degree in a science discipline (preferred) or equivalent combination of specialized training and relevant work experience.

• Previous experience of GMP documentation reviews with strong attention to detail

We are an Equal Opportunity Employer and do not discriminate against

any employee or applicant for employment because of race, color, sex,

age, national origin, religion, sexual orientation, gender identity,

status as a veteran, and basis of disability or any other federal,

state or local protected class.