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Job Description: 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 time point 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 Third Party Facility including but not limited to inventory control, sample receipt support, labeling, sample destructions, sample pulls and oversight of sample 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.
KNOWLEDGE AND SKILL
• 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
• Knowledge and understanding of ICH Guidelines for method validation and transfer 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 and Trackwise skills are desired.
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).
Take action, final decision, may work on assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. 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.
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Axelon Services, Corp is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, gender identity, national origin, disability, or protected veteran status.