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Apollo Professional Solutionshttps://www.apollopros.com/wp-content/uploads/2022/05/ApolloLogo600.pnghttps://www.apollopros.comhttps://www.apollopros.comUSD29.65.HOURtrue
Bachelor’s degree with previous experience in an appropriate scientific discipline (Biochemistry, Biomedical Engineering, Chemical Engineering or related discipline consisting of a combination of appropriate education, training and/or directly related experience)
Knowledge of GxPs and their application in the pharmaceutical environment.
Ability to interact with cross-functional teams while representing the stability group.
Able to navigate external vendor sites and portals for data extraction and review, as needed.
Able to communicate findings effectively to colleagues within and outside of the group through presentations.
Proficient with various MS Office programs, including Word, Excel, Outlook, and PowerPoint
Able to organize his/her own work on a routine basis and requires minimal supervision. When asked, the individual is able to provide updates and tracking on his/her tasks.
The ability to communicate verbally and in a written format.
Able to understand and follow written procedures.
The duties of this role are generally conducted in an office/lab environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
Job Description:Â Â Stability Associate
The Stability Associate II is responsible for performing assigned tasks to support stability activities for the client’s clinical phase Biological candidates. The Stability Associate II will work in collaboration with members of Analytical Sciences (AS), Biological Drug Substance Development (BDSD), Injectable Drug Product Development (IDPD), Device Development (DD), Quality Assurance (QA), and other members of Product Development and Clinical Supply (PDCS) as well as external vendors as required.
Responsibilities:Â Â Stability Associate
Responsible for all aspects of on-site stability sample storage and sample management.
Conduct Stability sample pulls at scheduled timepoints according to approved stability study plans.
Deliver stability samples to labs and perform aliquots as needed, following Good Documentation Practices (GDPs) and Good Laboratory Practices (GLPs)
Point-of-contact between on-site testing labs and stability group.
Author stability Protocols, Reports, SOPs and Quality documents as required.
Work with internal stakeholders to provide testing requirements and obtain completed analytical test results.
Track stability results generated internally and at external CMOs/ CLOs
Document stability results with a strong attention to detail; able to recognize trends outside of expected results and communicate to management as required.
Perform data entry/verification as required.
Perform all job functions in compliance with cGMPs and maintain accurate and legible records.
Ensure training is current for all job functions performed. Attend all required Company training.
Additional Preferred Skills:Â Â Stability Associate
Strong working knowledge of governing documents/regulations for pharmaceutical stability.
Knowledge of Lean Six Sigma.
Previous technical writing experience.
Previous experience with SAS JMP or other statistical software.
Previous experience with Laboratory Information Systems (LIMS).
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EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.
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