Stability Coordinator

King of Prussia, PA
March 29 2021
Other, Other
Organization Type
This individual 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 individual will play a key role in ensuring the testing windows for the new and scheduled set downs and pulls are maintained. The role will require timely communication with the management lines, contract labs and matrix/project teams on the adherence of project timelines and quality concerns.

This individual will also be responsible for ensuring samples are received, inventoried and set down in the appropriate storage conditions. Activities including arranging for shipments with third party logistics providers are an essential part of the role to ensure the controlled temperature units are maintained according to their maintenance programs. Off hour coverage should be considered part of the role (when required).

This individual will be required to remain informed of current GSK, FDA and industry standards related to areas required to support the duties of the role.

Key Responsibilities:
  • 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

Why you?

Basic Qualifications:
  • Bachelor's degree in biochemistry, analytical chemistry or an associated field
  • Minimum of 5 years' experience in the biopharmaceutical industry.
  • 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
  • Strong familiarity with FDA/EU/ICH/ROW regulations and guidance
  • Strong familiarity with Microsoft office based electronic systems and electronic document systems

Preferred Qualifications:
  • Excellent communications skill, ability to interact with both internal and external parties
  • Ability to work both independently and within a team environment

W hy GSK?

Our values and expectationsare at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
  • Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk
  • Managing individual and team performance.
  • Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
  • Implementing change initiatives and leading change.
  • Sustaining energy and well-being, building resilience in teams.
  • Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
  • Developing people and building a talent pipeline.
  • Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
  • Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
  • Budgeting and forecasting, commercial and financial acumen.

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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