Stability Associate Scientist

Title: Stability Associate Scientist

Duration: 6 Months

Location: Onsite role, Devens site

Work Schedule: Mon - Fri, Business Hours

Pay Range - $35.00 to 41.93/hr on w2

Job Description:

• Data entry and verification in the electronic laboratory inventory management system (LIMS)
• Monitor and assess stability data, pull data reports at the end of timepoint testing.
• Perform data verification and report unusual trends to management for review.
• 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.
• 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.

Knowledge & Skills:

• Knowledge of science generally attained through studies resulting in a science, engineering, biochemistry, a related discipline or its equivalent.
• Minimum 2 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 ahigh 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.

Contacts:

• 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.

Working Conditions:

• 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).

Decision Making:

• 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.