Stability Scientist

STABILITY SCIENTISTDEVENS, MA Required Skills: Top Skills:

• Communication, computer and problem solving skills are a MUST.

• Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry, a related discipline or its equivalent.
• Minimum 4 years of experience
• Problem solving ability, interpersonal, oral and written communication skills; as well as technical writing skills.
• Able to prioritize objectives from multiple projects, adhering to scheduled timelines.
• Work independently and contribute to a team based environment, promoting a high commitment to business goals and objectives.
• Computer skills required: Microsoft Office applications. LIMS skills are desired.
• Lead investigator and/or Quality Assurance experience is preferred, but not required.

• Provide Stability Administration Support for the department, including but not limited to study administration, maintenance, etc.
• Draft study protocols and support management of study programs as required.
• Support document management activities and author and/or revise GMP documents.
• Data entry and verification in the electronic laboratory inventory management system (LIMS)
• Monitor and assess stability data, pull data reports at the end of time point testing and prepare trend graphs; Perform data verification and report unusual trends to management for review.
• Support activities of Stability Third Party sample storage facility including but not limited to inventory control, sample receipt support, labeling, sample destructions, sample pulls and oversight of sample deliveries, etc.
• Ensure training requirements are met.
• Maintain the office and stability facility in accordance with cGMP.
• Initiate and promote change as part of operational excellence.

• Direct daily interaction with all staff and management of Quality Control Chemistry.
• Regular interaction with all departments within the facility as required in the conduct of assigned work.
• Occasional interaction with personnel from other sites to ensure alignment of sample shipping and receipt processes.

• The work environment may consist of a combination of the following: Office space, Inside Work, Outside Work, Working Alone, Working with/around others, Extremes (Heat/Cold), Heights, Dust/Mist/Fumes/Wet, Damp/Walking or Work Surfaces, Chemicals.
• The physical demands of the job may include but are not limited to: Unassisted lifting of items, not to exceed 50 lbs., Bending/Stooping, Twisting, Crouching/Squatting, Kneeling, Sitting, Crawling, Walking-Level Surfaces, Climbing (Ladder), Reaching (Shoulder), Repetitive (Use of Arm, Hands, Wrists).

• Exercises judgment within generally defined practices and policies in developing improved business processes. Coordinates with customers and technical experts on decisions and applies appropriate notification to management.