Assistant/Associate Scientist

Artech Information Systems LLCEast Syracuse

On-site Full-time

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Experience Level

Entry Level

Qualifications

Specific Knowledge, Skills, Abilities: • Understanding of ICH Guidelines (Q1A, Q5C) alongside BMS policies and directives.• Strong problem-solving skills, along with effective interpersonal, oral, and written communication capabilities; proficiency in technical writing.• Ability to prioritize objectives from multiple projects while adhering to strict timelines.• Ability to work independently while contributing to a team-oriented environment, demonstrating a high commitment to business goals.• Proficiency in Microsoft Office applications, SAP, LIMS, Trackwise, and similar software tools. Education/Experience/ Licenses/Certifications: Bachelor's degree in a scientific discipline with a minimum of 1-2 years of relevant experience.

About the job

POSITION SUMMARY:

As a Stability Scientist, you will play a vital role in supporting the Quality Control Stability program in Syracuse. This entails administering stability studies that are crucial for site manufacturing, as well as overseeing stability programs for other locations and Third Party Manufacturers (TPMs).

Duties/Responsibilities:

1. Assist in program administration by managing a schedule of pull dates for testing, preparing for, or overseeing sample pulls as required by the timeline.
2. Draft study protocols and aid in the management of study programs as needed.
3. Monitor and evaluate stability data, generate pull data reports post-testing, and prepare trend graphs; conduct data verification and report any unusual trends to management for evaluation.
4. Provide Stability LIMS Administration Support for the department, including study administration, maintenance, and training.
5. Support the operations of the Stability and Reserve Sample Facility, including unit maintenance, inventory control, sample receipt and destruction, sample pulls, and deliveries.
6. Ensure compliance with training requirements.
7. Author and/or update GMP documents.
8. Maintain the office and stability facility in compliance with cGMP standards.
9. Initiate and advocate for changes as part of operational excellence.

About Artech Information Systems LLC

Join a leading pharmaceutical organization renowned for its commitment to quality and innovation.

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