Quality Control Compliance Specialist

As Quality Control Compliance Specialist, you will author QC umbrella SOPs, such as OOS, B40 Flows, and Material Control. This position serves as a Lead Investigator for select QC Unplanned Events, as well as coordinator for a selected QC Change Controls. This person will also author QC Technical Documents, such as utility trend reports and deviation/event trend reports, will manage SQC and ORM KPIs for QC, and will execute QS tasks as per established timelines.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following...

• Drive a strong safety culture within QC and the site.
• Adhere to all established EHS policies and procedures.
• Manage Non-Testing umbrella processes that cross QC.
• Author SOPs, collaborate with network to optimize and align processes. Includes: OOS, Raw Data Management, Material Control, B40 Cleaning record review, and Building Flows SOPs.
• Serve as custodian of Utility testing results in SAP and SME on Utilities for audit purposes as well as CCs.
• Serve as Lead investigator for Lab Support Unplanned Events.
• Perform QS tasks within established timelines.
• Serve as author/coordinator for QC Change Controls and CAPAs
• Collaborate with QC teams, global team, support teams, and other sites to ensure compliant processes.
• Benchmark with GSK sites to ensure processes are optimized and in alignment within the network.
• Responsible for the on-time completion of L1/EHS audits, Utility Trend Reports, Deviation/Event Trending, and PQRs.
• Maintain QC KPIs. Create QC ORM and SQC slides. Update KPIs on Tier boards.
• Back-up ASAT- QC Specialists (if required)

Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

• Bachelor's degree
• Minimum of 3 years experience in cGMP-regulated environment.
• 3 years' previous experience with validation, calibration, or laboratory equipment/instrument maintenance.
• Minimum 2 years' experience in quality investigations

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

• Working knowledge of pharmaceutical facilities and processes.
• Knowledge of GMP's, NIH Guidelines, FDA and other regulatory agency requirements sufficent to apply to quality operations and compliance.
• The ability to communicate both verbally and in writing with all levels both inside and outside of the organization.
• The ability to clearly write technical documentation as necessitated by regulatory agencies and internal policy.
• Ability to establish and maintain working relationships with staff and the ability to analyze data and implement changes.
• Must be able to address complex problems associated with assessing deviations, determination of root cause, and implementation of change and improvement to validated and/or FDA approved production systems.
• Must have an aptitude for facilitating a team environment and working independently toward the goal of completing product investigations.
• Participate in cross-functional deviations as needed.
• Strong technical writing skills.

Why GSK?
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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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 Get Ahead Together.
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Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Why Us?
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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
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 workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We're committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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