As a Stability Coordinator, you will be responsible for the oversight and logistical requirements for stability samples associated with both internal and external assets. The role will include providing inputs to methods and stability protocols, scheduling testing with designated testing labs and ensuring data are analyzed and reviewed.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following
- Lead and coordinate stability study set downs, moves and pulls based on Stability and Release testing schedules
- Ensure release testing schedules and sample coordination is maintained
- Coordinate with on site service provider(s), internal and external partners and Stability Leads regarding logistics of release and stability set downs and pulls.
- Monitor and assist any compliance issues related to stability studies, including but not limited to Deviations/Investigations, Out of Specification, Quality Audit and Inspections, Change Controls and Training
- Maintain Stability Chambers, stability associated rooms including the work processes associate with the use and maintenance of the controlled temperature units.
- Keeping the stability infrastructure in an audit ready state
- Ensuring local procedures are current with global policies and industry expectations as well as aligned with GSK’s policies regulatory expectations.
- Maintain Stability Study Protocols, both inside and outside of validated LIMS systems to ensure the continued adherence to study requirements
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s degree in biochemistry, analytical chemistry or an associated field of study
- 5 years’ of experience in the biopharmaceutical industry
- Working knowledge of biopharmaceutical quality control experience in associated analytical methods such as SDS-PAGE, ELISA, cIEF, SEC, HPLC and Immunoassays.
- Experience with method qualification/validation, analytical testing and stability testing
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- Strong familiarity with FDA/EU/ICH/ROW regulations and guidance
- Strong familiarity with Microsoft office based electronic systems and electronic document systems
- Excellent communications skill, ability to interact with both internal and external parties
- Ability to work both independently and within a team environment
Today there are still millions of people without access to basic healthcare, thousands of diseases without adequate treatments and millions more people who suffer from everyday ailments. At GSK we want to change this.
As a global healthcare company, we take on some of the world’s biggest healthcare challenges. By delivering a sustainable business, we provide health benefits to patients and consumers, improved shareholder returns as well as supporting wider society. We have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
We are committed to widening access to our products, so more people can benefit, no matter where they live in the world or what they can afford to pay. Each of our three businesses benefits from GSK’s commercial infrastructure, integrated supply networks and significant global presence.
As a global company, our reward packages are designed to meet the needs of our geographically diverse workforce. They are benchmarked against industry standards and relevant to your job, no matter where you live.
Our reward package includes:
- A competitive base salary
- An annual bonus that rewards you for your individual contribution to our strategy, as well as business targets
- Benefit programs designed to support you and your family, including access to healthcare and well-being programs, pension plan membership, savings programs, time off and childcare support
- Employee recognition programs which reward exceptional achievements
- Share ownership schemes which link your reward to GSK’s longer term performance
- A performance and development program that helps you identify what you need to do, and the behaviors you need to demonstrate, to achieve success.
