Project Coordinator II, Stability Quality Control
Arrowhead Pharmaceuticals
8 days ago
On-site
Madison, WI
Operations
The Stability Coordinator is responsible for assisting in the oversight and management of Arrowhead’s stability program. Key responsibilities include preparing stability samples for study initiation, tracking timepoint pull dates, performing sample pulls, maintaining testing data forms and reports, providing study documentation oversight, coordinating with contract vendors for analytical testing and sample storage, and reconciling and disposing stability samples upon study completion.
Responsibilities:
- Work cross-functionally with Manufacturing to ensure release and stability samples are received and transferred to testing lab(s).
- Author, review, and revise stability documents (protocols, work instructions, stability reports).
- Perform stability study initiations.
- Assist with stability timepoint pull schedules and perform timepoint sample pulls.
- Manage samples (reconcile inventory, sample location, and distribution to testing lab[s]).
- Coordinate shipments and sample analyses with external testing laboratories/storage facilities.
- Assist with routine maintenance of stability chambers.
- Manage stability program data/reports; maintain study folders; compile and interpret stability data.
- Ensure results are complete, accurate, and documented per ALOCOA++ standards.
- Assist with set down and management of internal/external retain and reserve samples.
- Provide oversight of stability processes and improvements; other duties as needed.
Requirements:
- Bachelor’s degree in Chemistry (or related scientific field) with 2+ years relevant experience (pharmaceutical CMO/CRO).
- MS Office experience (Excel, Word, PowerPoint).
- Strong verbal and written communication; cross-functional teamwork.
- Solid organizational skills; ability to adapt to changing priorities/deadlines.
Preferred:
- Knowledge of cGMP/cGLP and ICH/FDA guidance.
- Stability program and sample handling experience.
- LIMS system experience.
- Smartsheet (or similar).
Wisconsin pay range: $70,000 USD - $80,000 USD
Responsibilities:
- Work cross-functionally with Manufacturing to ensure release and stability samples are received and transferred to testing lab(s).
- Author, review, and revise stability documents (protocols, work instructions, stability reports).
- Perform stability study initiations.
- Assist with stability timepoint pull schedules and perform timepoint sample pulls.
- Manage samples (reconcile inventory, sample location, and distribution to testing lab[s]).
- Coordinate shipments and sample analyses with external testing laboratories/storage facilities.
- Assist with routine maintenance of stability chambers.
- Manage stability program data/reports; maintain study folders; compile and interpret stability data.
- Ensure results are complete, accurate, and documented per ALOCOA++ standards.
- Assist with set down and management of internal/external retain and reserve samples.
- Provide oversight of stability processes and improvements; other duties as needed.
Requirements:
- Bachelor’s degree in Chemistry (or related scientific field) with 2+ years relevant experience (pharmaceutical CMO/CRO).
- MS Office experience (Excel, Word, PowerPoint).
- Strong verbal and written communication; cross-functional teamwork.
- Solid organizational skills; ability to adapt to changing priorities/deadlines.
Preferred:
- Knowledge of cGMP/cGLP and ICH/FDA guidance.
- Stability program and sample handling experience.
- LIMS system experience.
- Smartsheet (or similar).
Wisconsin pay range: $70,000 USD - $80,000 USD