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QA Compliance Specialist Full-time

at GlaxoSmithKline in Maryland (Published at 12-02-2019)

Job Description

As an Operational QA Manager, you will be responsible for providing effective and efficient support to the Local Operating Country (LOC) Quality Manager to maintain effective Quality Management System (QMS) and perform LOC Quality Operation activities in compliance with GSK Policies, QMS and local regulations.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:

  • Execute and deliver Local Operating Country (LOC) Quality Objectives and LOC Quality Improvement Plan.
  • Perform trending of Quality KPIs to support continuous improvement at the LOC.
  • Maintain a robust, sustainable and effective QMS (Quality Management System) at the LOC to ensure LOC Quality operations and processes are in full compliance with GSK standards and policies, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and local regulatory requirements.
  • Responsible for quality performance of the assigned 3rd party contractors/ service providers/ suppliers and ensuring potential quality and compliance issues are identified, communicated and promptly resolved.
  • Ensure quality systems are in place and in use according to GSK QMS standard.
  • Coordinate LOC Quality Council meetings.
  • Participate in LOC Quality Council(s) in identifying Quality related issues and continuous improvement Opportunities.
  • Perform activities to support risk management process to ensure timely mitigation of quality risks.
  • Perform quality impact assessment to ensure all planned changes at the LOC are appropriately managed.

are appropriately managed through change control.

  • Perform self-inspections at the LOC and 3rd party service providers? operations with potential product quality and regulatory compliance impact.
  • Support investigations and root cause analysis in response to deviations, quality issues, audit findings and customer complaints.
  • Ensure product supplied to market have the right quality, safety, efficacy and comply with local regulations.

Why you?

Basic Qualifications:

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

  • Associate degree
  • 5 years of experience in life sciences industry in Quality Assurance role
  • Experience with cGMP (Clinical Good Manufacturing Practices) in pharma testing/secondary repacking
  • Operational experience with Good Documentation Practices (GDP) in warehousing and distribution

Preferred Qualifications:

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

  • Bachelor?s degree
  • Ability to engage and works well works well in cross-functional teams
  • Ability to multi-task and work under pressure

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

  • Operating at pace and agile decision-making ? using evidence and applying judgement to balance pace, rigour and risk.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Continuously looking for opportunities to learn, build skills and share learning.
  • Sustaining energy and well-being.
  • Building strong relationships and collaboration, honest and open conversations.
  • Budgeting and cost-consciousness.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK HR Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK?s compliance to all federal and state US Transparency requirements. For more information, please visit GSK?s Transparency Reporting For the Record site.

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