Job Information
GlaxoSmithKline Consumer Healthcare, L.P. QC Technical Expert in Hamilton, Montana
Site Name: USA - Montana - Hamilton
Posted Date: Aug 7 2024
The QC Technical Expert will utilize technical knowledge to provide a robust management of QC Methods while ensuring compendial compliance across the QC Analytical Assays.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Ensure local SOPs and method validation is in alignment with current compendia.
- Perform Method Development and Method Transfer in collaboration with MSAT.
- Oversee QC Method Validation and Material Qualification Program. This may include but is not limited to: drafting protocols, protocol execution, review of in-place/in-use, method robustness review, manage Analytical Validation Master Plan
- Use technical knowledge of assays to aid in equipment and/or assay troubleshooting.
- Identify and drive innovative technology improvements across the QC assays/equipment in collaboration with MSAT, Sterility Assurance and global QC network teams.
- Continuous Method Verification (CMV) Hamilton system owner/steward
- Monitor method robustness: identify and drive improvements across assays in alignment with department and site strategy.
- TLCT SPOC for QC Hamilton.
- Stability program administration.
- Ability to establish best practices across labs (weighing, pipetting, volumetric transfers, etc) to reduce variation between operators.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor's Degree in Scientific field
- 5+ years of experience in a GMP Laboratory role
Preferred Qualifications:
- Strong technical writing capabilities
- Strong soft skill capabilities (communication, influence, feedback, etc)
- Ability to work across boundaries (within QC, within Hamilton, within GSK networks)
- Strong technical knowledge across the following disciplines (or the ability to obtain within 6 months): Chromatography (HPLC, UPLC, UV-MS, GC), Bioburden (membrane filtration, direct inoculation), Endotoxin, Spectrophotometers, Karl Fischer, Particle Sizer, FTIR
- Background using Lean Six Sigma and/or DMAIC methodology
- Statistical analysis of data with the ability to identify and investigate trends
- Strong time and task management capabilities
- Ability to work independently as well as with a team
- Knowledge of USP and EP Compendia
- SAP experience
- Equipment maintenance and troubleshooting experience
- Proven capabilities related to laboratory techniques (ie. weighing, pipetting, volumetric transfers, etc)
- Effective approach to training others
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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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