Pharmaceutical Stability Specialist
The Pharmaceutical Stability Specialist is responsible for ensuring that all samples are entered into the Laboratory Information Management System (LIMS) and made available to the lab staff in a timely manner. Coordinates and maintains stability studies in accordance to FDA, cGMP and Boston Analytical’s Standard Operating Procedures. This position reports to the manager of Stability and Sample Management. The Specialist’s responsibilities include, but are not limited to, the following:
Primary Duties and Responsibilities
- Coordinate, maintain, and direct stability studies. Includes setup of study in LabWare LIMS, storage of samples in validated chambers, and removing samples at designated time points for testing internally or to prepare for shipment to client.
- Review work completed by peers for accuracy and adherence to cGMPs, SOPs, company and client documents.
- Author and/or review pertinent stability documentation including protocols.
- May be required to act as spokesperson or subject matter expert with regard to stability on behalf of the company.
- Responsible for receipt and entry of samples.
- Performs any combination of sample management tasks, including labeling, preparing for shipping, transporting to labs, inventorying and disposing.
- Reviews and verifies sample paperwork against samples to ensure accuracy and communicate discrepancies. Distributes sample information and paperwork.
- Provides mentorship and leadership to peers.
- Perform response and impact analysis for chamber excursions as needed.
- Direct and prioritize work in the department as needed.
- Properly handles, stores and disposes of hazardous materials according to OSHA and Boston Analytical procedures.
- Ensures all work performed strictly adheres to cGMP, company and client
- Follows good documentation practices.
- Follows all safety rules and regulations.
- Follows all cGMP rules and regulations.
A Bachelor’s degree in a scientific discipline with 3-5 years of related work experience or 5-8 years without a Bachelor’s degree required. Proficient computer skills are required. Experience with cGMP, ICH, and LIMS is preferred. Knowledge of QC Chemistry or Microbiology testing is a plus.
Minimum Skills Requirements:
Must have the ability and skill to perform the detailed job requirements noted above competently, safely, accurately and proficiently. Self-starting motivated person who possesses excellent time management, ability to adapt to change and organizational skills. Must have an ability to complete tasks efficiently and have excellent interpersonal skills to be able to clearly communicate with the manager, peers and internal customers. Must be detail oriented and able to complete risk assessments for samples and documentation. Must be a team player with integrity and concern for the quality of Company products, services and staff members.