POSITION SUMMARY:
The role of the Stability Scientist is to support the activities of the Syracuse Quality Control Stability program which includes stability study administration to support site manufacturing; as well as, stability programs for other sites and Third Party Manufacturers (TPM).
Duties/Responsibilities:
1. Support program administration by maintaining a schedule of pull dates required for testing, preparing for or providing oversight for the sample pulls as required by schedule.
2. Draft study protocols and support management of study programs as required.
3. Monitor and assess stability data, pull data reports at the end of timepoint testing and prepare trend graphs; Perform data verification and report unusual trends to management for review.
4. Provide Stability LIMS Administration Support for the department, including but not limited to study administration, maintenance, training, etc.
5. Support activities of Stability and Reserve Sample Facility including but not limited to unit maintenance, inventory control, sample receipt and destructions, sample pulls and deliveries, etc.
6. Ensure training requirements are met.
7. Author and/or revise GMP documents.
8. Maintain the office and stability facility in accordance with cGMP.
9. Initiate and promote change as part of operational excellence.
Specific Knowledge, Skills, Abilities, etc:
• Knowledge and understanding of ICH Guidelines (Q1A, Q5C) and associated BMS policies, directives and guidance documents.
• 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, SAP, LIMS, Trackwise, etc.
Education/Experience/ Licenses/Certifications:
Bachelor’s degree in a scientific discipline with a minimum of 1-2 years of relevant experience.
Physical Demands:
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).
Work Environment:
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.
Interested candidates may contact at "Praveen.arora(@)artechinfo.com or 973-507-7593"