Stability Protocols
Generates and maintains marketed/development product stability protocols. Prepares and /or reviews study initiation paperwork for marketed/development products as needed. Utilizes understanding of regulatory environment and industry trends to identify ways to improve process quality and compliance. Ensures the setup/routine maintenance/ calibration/ repair activities for chambers including coordination/ escort/monitoring of contract services and work order/permits and general housekeeping of the chambers. Generates change controls
Stability Samples Pulled & Submitted for Testing
Pulls stability samples and delivers to laboratories as scheduled. Assists in the disposal of expired samples and documentation of destruction. Creates worksheets/test forms for each sample/lab pull. Assists in the labeling and storage of new marketed and developmental stability samples.
Stability Reports Support Regulatory Commitments
Ensures that Commercial stability commitment lots are pulled from production and tested per protocol, and annual reports are written to satisfy regulatory requirements. Maintains the electronic inventory stability database. Formats or oversee the formatting stability data tables for new studies. Reviews product stability laboratory testing documentation packets. Performs or reviews data table entries. Notifies management of any atypical data or trends. Provides data and graphical review for developmental stability reports. Provides stability information, reports and tables upon request. Provides input for deviations, investigations, and corrective actions. Performs routine support functions for stability administration including, but not limited to: data table creation and entry and review, filing, and stability study initiation.
Uses laboratory and stability information systems to retrieve data and information. Performs regression analyses and expiry dating evaluations as needed. Revises SOPs and forms; performs regression analysis. Generate billing for customer invoices. Communicate pull schedules, generation of data, and sending reports to customers/external manufacturing.
Education:
Bachelor's Degree in Chemistry, Chemical Engineering, related science or equivalent combination of Education, or equivalent Experience and Competencies.
Experience:
Must have previous experience in cGMP environment, preferably in a pharmaceutical stability program.
Preferred Skills/Qualifications:
- Ability to quickly learn new laboratory/stability information systems
- Ability to evaluate data, perform trend analyses, identify potential issues, propose and implement solutions.
- Ability to comply with SOP's, cGMP's, HS&E requirements, and FDA, DEA, and OSHA regulations.
Other Skills/Competencies:
- Perform reading, writing and speaking at an advanced level
- Basic computer skills including Word, Excel and database software(s)
Organizational Relationship/Scope:
- Attention to Detail: Is thorough and precise in accomplishing a task through concern for all the areas involved, no matter how small; monitors and checks work or information and plans and organizes time and resources efficiently; double-checks the accuracy of information and work product to provide accurate and consistent work; provides information on a timely basis and in a usable form to others who need to act on it; remains aware and takes care of details that are easy to overlook or dismiss as insignificant; compares observations of finished work to what is expected to find inconsistencies.
- Customer Focus: Is dedicated to meeting the expectations and requirements of internal and external customers; gets first-hand customer information and uses it for improvements in products and services; acts with customers in mind; establishes and maintains effective relationships with customers and gains their trust and respect.
- Decision Quality: Makes good decisions (without considering how much time it takes) based upon a mixture of analysis, wisdom, experience, and judgment; most of his/her solutions and suggestions turn out to be correct and accurate when judged over time; sought out by others for advice and solutions.
- Time Management: Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend to a broader range of activities.
- Written Communication: Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect.
Mallinckrodt Pharmaceuticals
Jun 05, 2025