Description:
Stability Scientist is responsible for providing stability program operational support for stability studies managed by Global BioPharmaceutical Stability and for overall department administration support.
Duties/Responsibilities Key activities
- Oversees and supports stability team by managing stability study inventory, including receipt of samples from manufacturing site, placing samples at the appropriate conditions per approved protocols, managing timepoint pull schedules and samples pulls with the testing labs, storage unit maintenance, inventory control, sample destructions, sample pulls and deliveries, inventory management and reconciliation. Assists with review of stability data and trends.
- Oversees and support identifying stability annual requirements from the manufacturing site via stability annual requirement documents and enrollment document.
- Support stability program activity execution for the current and new products. Engage with generation of sample management program and logistics, master stability protocol, stability study protocol. Review stability study LIMS build for accuracy with respect to sample management.
- Identify, write, and revise applicable SOPs for managerial review and approval.
- Write applicable technical reports section for sample storage and sample management pull information for OOS/OOT investigations as needed.
- Write and revise annual stability requirement documents (PAR/QSR, SAR/YER).
- Escalate information regarding stability program management that may impact lab capacity, product studies or regulatory commitments directly and promptly to management.
- Provide team training need for ongoing stability activities. Ensure training requirements are met.
- Works according to cGMP requirements and HA expectations.
- Can effectively interact with inspectors during facility tours.
- Support stability storage chamber maintenance by working with third party contractors and site maintenance personnel, providing entry of work orders in designated systems, maintaining, and reviewing environmental charts and log sheets and responding to chamber related events.
- Enters test results from contract laboratories into the stability study management systems.
- Provides administration support for department training, financial, filing, and archiving processes.
These key activities provide support in order for the department to achieve defined company and business goals.
Qualifications, Knowledge And Skills Required Education
- Bachelors Degree in Chemistry, Microbiology, or other related scientific discipline
Experience/Knowledge
- Experience with stability programs desired.
- Solid understanding and knowledge of cGMPs and regulatory principles.