Stability & Sample Management Manager
The stability and sample management manager will direct, oversee, coordinate and maintain all activities in the stability and sample management department. This includes, but are not limited to, the following: Managing the set up and execution of all studies and all other samples conducted at Boston Analytical. The supervision and performance of logging in all studies and the generation of corresponding WIP’s. Ensuring that all documentation and associated request forms are accurate. Working closely with client services, clients, metrology and laboratory management to achieve these objectives.
Primary Duties and Responsibilities
- Manage and direct the Stability and Sample Management Coordinators.
- Manage receipt and log-in client samples using the LIMS to ensure accuracy.
- Develop, author and implement stability protocols and reports.
- Set up, coordinate and monitor on-going stability studies.
- Verifying accuracy of stability protocols and request forms.
- Oversee the removal of samples during designated intervals, keeping accurate inventory and pull records.
- Generation and revision of all records relating to updating and/or cancellation of existing stability projects.
- Oversee all stability samples for tests that are outsourced.
- Interacting with client services, clients or sales when questions arise with stability protocols and associated request forms.
- Manage inventory of stabilities and have the ability to forecast future needs.
- Work closely with metrology to manage chambers.
- Write impact statements for chamber excursions.
- Properly handle, store and dispose of hazardous materials according to OSHA and Boston Analytical procedures.
- Ensures all work performed strictly adheres to cGMP, Company and client documentation.
- Communicate issues with client service or sales as needed.
- Follows good documentation processes.
- Follows all safety rules and regulations.
- Follows all cGMP rules and regulations.
Qualifications include a BS degree in a scientific discipline preferable in chemistry, biochemistry, pharmaceutical sciences, or related technical field with 2-4 years of related experience required. Computer skills and experience with cGMP is required. Familiarity with LIMS is desired.
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, multi-tasking and organizational skills. Must have an ability to prioritize and complete tasks efficiently and have excellent interpersonal skills who is able to effectively interact with all departments within the Company. 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.
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