QC System Support Specialist

Location

Hamilton, OH | United States

Job description

Site Name: USA - Montana - Hamilton
Posted Date: Jan 26 2024

The QC Systems Support Specialist will m anage non-testing laboratory support systems and processes for QC, including: Maintaining SAP Modules, Master Data/Monograph Creation, Compendial Review, Equipment Qualification/Lifecycle, and Method Validation/Transfer.  Serve as a Lead Investigator for select QC Unplanned Events, as well as change coordinator for selected QC Change Controls. Author QC Technical Documents, such as validation and trend reports and provide data for annual PQR. Works collaboratively with global teams (ASAT) and the GSK network to maintain compliance and alignment, and to deliver both local and global projects 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:

• Provides leadership to complex lab investigations, trouble-shooting equipment and assays, preparation/execution of validation/qualification protocols, LSOP revision/review and the resolution of complex lab investigations.
• Perform non-routine tests, studies or projects and communicate results to key customers.
• Lead the qualification, operation and scheduled maintenance of laboratory equipment, including automated and computerized systems and assure they remain in a functional, validated state.  Escalate issues associated with equipment and assays as required.
• Author and/or execute Change Control, Deviation, CAPA documents and lab investigations (EHS, Deviation, AR, OOS, etc.) as necessary.
• Understand and comply with current GMP regulations and quality systems.  Promotes a quality mindset in every action, every day by routinely communicating concerns, issues and best practices.
• Accountable for supporting QC and site operations, communicating in a positive, professional manner, supporting operational excellence principles and supporting and implementing management decisions
• Responsible for application of GSK safety and environmental guidelines and identification, escalation and prevention of safety issues.  Lead risk assessments (CRA, WRA, etc.) and propose departmental risks.  Duties may include minimal handling of hazardous waste from laboratory activities to satellite storage areas. Annual training on area-specific hazardous waste handling is required. This training satisfies annual RCRA training requirement for large quantity generators and is part of the site’s RCRA compliance program.
• Maintain area of responsibility in a state of inspection readiness and perform self-inspections.
• Provide support for global initiatives such as Data Integrity and LES.
• Performs other departmental duties as assigned by management.

Why you?

Basic Qualifications:

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

• Bachelor's Degree in a scientific discipline.
• Experience in a cGMP laboratory

Preferred Qualifications:

• Excellent written and verbal communication skills.
• Proficient in standard MS software including Word, Excel, PowerPoint, Teams. 
• SAP, Change Control and Project Management experience preferred.
• Demonstrated ability to work successfully both independently and in a team environment.
• Excellent time management skills.

#LI-GSK

#LI-Onsite

Please visit  GSK US Benefits Summary t o 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.

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

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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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