QA Compliance Specialist (Biotech)
Are you energized by a quality assurance role that allows you to accelerate compliance in a state of the art manufacturing environment? If so, this QA Compliance Specialist role could be an ideal opportunity to explore.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
• Track and assess supplier initiated changes and vendor complaints.
• Manage change control associated with supplier changes.
• Manage data collection forms for supplier related changes.
• Manage data collection forms for new and changed part numbers.
• Support site Inspection Readiness initiatives including self-inspections, monitoring audits, third- party and regulatory inspections.
• Support Data Integrity reviews at the site.
• Trained as a site Qualified Internal Auditor and participate in at least 2 monitoring audits a year and working towards the competency to be a Lead Auditor.
• Manage GMP documents by writing, reviewing, and/or managing document workflows
• Provide metrics and Key Performance Indicators (KPIs) for management of risks and compliance
We are looking for professionals with these required skills to achieve our goals:
If you have the following characteristics, it would be a plus:
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:
If you require an accommodation or other assistance to apply for a job at GSK/ViiV Healthcare, please contact your local HR department.
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
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.
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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.