Location: Marietta,PA, USA
Site Name: USA - Pennsylvania - Marietta
Posted Date: Oct 29 2024
Are you interested in working with cutting-edge laboratory technology to improve quality and accelerate regulatory compliance? If so, this Quality Control Support Supervisor role could be an exciting opportunity to explore.
As Quality Control Support Supervisor, you will have responsibility for providing leadership to Lab Support Team in order to manage non-testing processes within QC. This includes: Sample Management, Stability, Compendial Review, QC Master Data/Monograph Creation, Auditing, Equipment Lifecycle, Performance Management. You will ensure tasks are executed within SLA timelines, drive projects to closure in support of site goals, and serve as owner for Lab Support Quality System Events. You will also ensure lab processes are safely executed and are compliant with GMP/regulatory requirements.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
* Drive QC safety culture by leading safety discussions and communicating ZAPS and HAZARD IDs.
* Ensure team compliance with safety policies.
* Provide leadership by motivating team-members, assisting in training programs for personnel, and troubleshooting laboratory equipment problems.
* Manage performance and development of team members to ensure team can execute tasks in a timely and reliable manner.
* Owner of non-testing processes within QC.
* Responsible for ensuring processes are optimized and meet regulatory requirements and that tasks are executed by team as per established schedules.
* Provide oversight to team to ensure Lab Support projects are well managed.
* Build relationships with global partners to identify and implement best practices, troubleshoot issues, share learnings, and align practices within the network.
* Ensure that methodology/documents are harmonized with other GSK sites as appropriate.
* Responsible for ensuring team manages QC equipment across lifecycle.
* Work collaboratively with QC Planner to ensure timelines for routine tasks and projects, are scheduled to meet required timelines.
* Attend meetings and act as an empowered SME of QC.
* Participate in regulatory audits and site investigations by acting as an SME. (Interpreting data, generating options, resolving problems, prioritizing solutions, selecting optimal solutions and implementing decisions)
* Support the timely resolution of audit findings or site investigations for QC related activities.
* Author and/or review associated documentation.
* Escalate concerns, risks/issues, delays to testing, and oos results to QC Manager and stakeholders.
* Own Quality System Events/Documents for Lab Support Team including, Laboratory Standard Operating Procedures, Analytical Methods, Unplanned Events, Change Controls, Specifications and other GMP documents such as monograph creation and revision.
* Ensure that methodology/documents are harmonized with other GSK sites as appropriate.
* Ensure all compendial sampling and testing is up to date with relevant compendia.
* Decide when changes are required to existing procedures, sampling plans and testing.
* Act as back-up for QC Manager and QC Planner.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
* Bachelor's degree
* Minimum 3 years' experience in a laboratory of a high volume, rapid turnaround testing.
* Minimum 3 years' experience in a GMP/FDA regulated environment.
* Minimum 3 years' experience in Quality Control environment in a Microbiology, chemistry or Biology field.
* Minimum 2 years' experience in leadership.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
* Knowledge of GMP's, NIH Guidelines, FDA, and other regulatory agency requirements sufficient to apply to quality operations, compliance and interfacing with auditors.
* Serve as an SME (subject matter expert) in technical areas in order to provide information to others.
* Ability to interface with regulatory auditors.
* Understand when a topic must be escalated and carry out escalation.
* Sense of urgency, flexibility, and accountability.
* Knowledge of SAP
* Executive capability and leadership to manage people and field projects teams.
* Ability to communicate at all levels.
* Ability to work in a high complex matrix environment.
* Must be a committed team player prepared to work in and embrace a team-based culture.
* Ability to follow written procedures and document results in a neat and precise manner.
* Intermediate computer skills
* Proven record of providing excellent internal and external customer service.
* Stay current on developments in the field and GSK-Bio Standards.
* Maintain attention to detail, while completing multiple or repetitive tasks.
* Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.
* Maintain a high level of integrity while balancing multiple priorities and responsibilities.
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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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