Job Posting Title: Quality Engineer - Raw Materials
Description: The External Quality Engineer (Raw Material) manages the external quality systems in relation to raw material and commodity suppliers. These systems are but not limited to Supplier Corrective Action Report (SCAR), Change Control (CC), Corrective Action Preventive Action (CAPA), and Lab Investigation Reports (LIRs). The incumbent will work with the internal QC raw material group, QC Control Center and external quality data analytics support function for timeliness of deliverables.
• Provides technical expertise to external raw material supplier, creates and approve protocols and reports for, and participates in as needed for simple or complex tests, the transfer of such tests, or qualification of equipment
• Manage testing of raw materials and provide support for implementation and ongoing support of the raw materials supplier qualification program.
• Review and approve development and Implementation of Identity testing for compendial and non-compendial custom raw materials.
• Supports thorough, well documented, and timely laboratory deviation/investigation reporting at raw material suppliers.
• Effectively utilize Change Management to support raw material suppliers.
• Maintain and improve GMP compliance and documentation and ensure integrity of QC data for support of regulatory submissions.
• Solid knowledge and proficiency with analytical and compendial methodology in relation to raw materials and commodities. Experience with adventitious safety testing of raw materials is helpful, process intermediates and cell bank. Experience in RM qualification.
• Must possess excellent communication (oral and written), organizational, and interpersonal skills with ability to multitask while working under restrictive timelines.
• Must be able to work in a team environment and perform job responsibilities under minimal supervision in office location or remote working location.
• Must be proficient with MS Office applications.
• Bachelor’s degree in chemistry, biology, or related disciplines and 3 years of experience in a Pharmaceutical (Biologics), Biopharmaceutical, and/or Biotechnology environment; or equivalent combination of education and experience.
• Prior experience working in a cGMP/GLP environment required.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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