QC Scientist / Chemist

Proclinical is currently recruiting for a QC Scientist/Chemist with a global pharmaceutical company located in King of Prussia, PA. Successful candidate will support management of Critical Reagent Program by assisting with qualification, distribution, and shipment of critical reagents, reference standards, and analytical cell banks to GLP and R&D laboratories globally.

Job Responsibilities:

• Maintain inventory of onsite critical reagents and reference standards.
• Support the QC Lab Operations with associated analytical method troubleshooting, process improvement, SOP and other quality document review/approval, business initiative/project management.
  Specific Accountabilities:
• Support the critical reagents/reference standard inventory program and support the effective transfer to and from sites.
• Assume responsibility for writing critical reagent Records of Analysis.
• Work closely within and across interdepartmental matrix teams to ensure harmonization of work processes.
• Work with QA, document control and validation groups to ensure quality standards are maintained and/or enhanced.
• As appropriate, be able to assume delegated duties associated with the Critical Reagents and Emerging Markets Group/ATTS.

Skills and Requirements:

• Bachelor's degree in biochemistry or analytical chemistry with a minimum of 1-year laboratory experience.
• Candidate be familiar with biopharmaceutical quality control or development laboratory environment and understand analytical methods (SDS-PAGE, ELISA, cIEF, SEC, CEX-HPLC, Immunoassay and Bioassay, USP/EP compendial testing).
• Experience with Cold Chain distribution, inventory management, and other supply chain management systems is highly desirable.
• Familiar with inventory management.
• Strong Project Management skills.
• Basic technical writing abilities and in-depth knowledge of cGMPs, biopharmaceutical manufacturing processes.
• Basic familiarity with FDA/EU/ICH and ROW regulations and guidance.
• Microsoft Windows experience required, with technical proficiency in Word, Excel, Empower, LIMS, and other laboratory IT systems typically used in the industry.
• Excellent written and verbal communication skills, ability to interact with both internal and external parties.
• Ability to work both independently and within a team environment.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Sarah Beshara at (+1) 267-477-3355 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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