West Chester, PA, United States
This position contributes to the successful timely sampling, inspection and releasing testing of raw materials and components, intermediates, in-process and drug substance of GMP clinical pharmaceutical manufacturing. Individual functions with supervision as an Associate Scientist and is actively engaged in analytical activities within a dynamic QC project team.
Duties & Responsibilities
Perform compendial testing (appearance, pH, osmolality, protein concentration, etc.) in support of release samples and in process testing.
Record data per GxP requirements. Provide peer review of documentation as needed.
Perform environmental monitoring and raw materials testing as requested.
Assist with sample maintenance as requested.
Participate in the writing/editing of standard operational procedures, forms and reports and data archiving as requested.
Maintain compliance with applicable ICH, GLP, GMP and safety regulations. Notify management of unexpected results, procedural deviations and equipment problems.
May participate in laboratory investigations.
May perform non-compendial analytical testing (e.g., chromatography –HPLC, UPLC).
Maintain a collaborative working relationship with QC staff and other Teva departments (Quality Assurance, Analytical Development).
Actively contribute to the maintenance of a clean, safe working environment in the laboratories
B.S. in Chemistry, Biology, Microbiology, or related sciences with 1-3 years of related experience.
Accurately and completely records experimental procedures, test results, and observations to meet corporate and cGMP requirements
Good understanding and application of scientific principles and techniques.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Ability to work effectively and diligently to meet deadlines.
Highly organized and motivated, have strong communication and presentation skills and the ability to multi-task, collaborate and work within a team environment.
Preparation of reagents/standards/medias as needed for analysis according to established methods
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
About Kelly Services®
As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.