BioSpace
Overview
This is a non-supervisory position within the Verification department of USP's Global Laboratory and Technical Operations (GLTO). The incumbent will conduct and implement activities related to current Good Manufacturing Practice (cGMP) site audits, quality control and manufacturing (QCM) product documentation reviews, and test design for conformance to applicable compendial standards. How you will create impact
You contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health. You will serve as the primary and/or secondary contact for participants in the verification program(s) and manage verification projects, working with participating companies and staff to ensure timely completion. You will prepare and/or evaluate cGMP site audits/reports, QCM documentation/reports, and test data/results for facilities and products undergoing verification. You will help develop and implement new tools, procedures, and techniques for the verification department to support growth of verification services as a center of excellence within USP. Responsibilities
Conducts thorough review and evaluation of quality control and manufacturing (QCM) documents and other data from manufacturers to ensure compliance with verification requirements. Prepares reports and communicates observations to participants to ensure corrective actions are taken where needed. Ensures compliance with verification procedures in the preparation of summary reports and approval letters for final disposition of verified products. Collaborates with verification staff, USP departments, contract auditors, and testing laboratories to coordinate work schedules for the verification programs. Conducts audits and coordinates with USP GMP auditors at USP Rockville and international sites to assist in thorough audits of program participants' facilities for drug substances, excipients, dietary ingredients, and dietary supplements. Performs surveillance activities to ensure audits and documentation reviews are conducted according to program requirements. Develops and revises standard operating procedures (SOPs) and participant manuals. Performs other duties as assigned. Education and Experience
M.Sc. degree in food science, analytical chemistry, biochemistry, or related fields. Minimum of five (5) years of relevant experience, or equivalent combination (e.g., B.S. with seven (7) years). Experience in cGMP facilities involved in manufacturing and/or QA/QC of foods, pharmaceuticals, and/or dietary supplements/ingredients. Industry Experience
Experience establishing quality systems compliance within the above fields. Willingness to travel approximately 10% domestically and internationally. Additional Desired Preferences
Extensive knowledge of FDA regulations pertaining to cGMP requirements. Knowledge of GMP audits using 21 CFR parts 111 and 117 is desirable. Regulatory interpretation, audit procedures, documentation, and Quality Assurance experience. ASQ Certified Quality Auditor (CQA) desirable. Familiarity with ICH guidelines and CTD for APIs; regulatory CMC submission experience is desirable. Analytical methodologies knowledge, good organizational and communication skills, detail oriented, and ability to handle multiple priorities. Project management experience is desirable. Third-party quality certification/verification experience is a plus but not required. Supervisory Responsibilities
None, this is an individual contributor role. Benefits
USP provides benefits including company-paid time off, comprehensive healthcare options, and retirement savings to protect your personal and family well-being. Compensation
Base Salary Range: USD $85,500.00 – $111,250.00 annually. Target Annual Bonus: varies by role. Individual packages are based on skills, experience, qualifications, equity, and other job-related factors. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. This employer provides rights information pursuant to federal employment laws. See Know Your Rights from the Department of Labor at eeoc.gov. Job Category
Chemistry & Scientific Standards Job Type
Full-Time
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This is a non-supervisory position within the Verification department of USP's Global Laboratory and Technical Operations (GLTO). The incumbent will conduct and implement activities related to current Good Manufacturing Practice (cGMP) site audits, quality control and manufacturing (QCM) product documentation reviews, and test design for conformance to applicable compendial standards. How you will create impact
You contribute to USP's public health mission of increasing equitable access to high-quality, safe medicine and improving global health. You will serve as the primary and/or secondary contact for participants in the verification program(s) and manage verification projects, working with participating companies and staff to ensure timely completion. You will prepare and/or evaluate cGMP site audits/reports, QCM documentation/reports, and test data/results for facilities and products undergoing verification. You will help develop and implement new tools, procedures, and techniques for the verification department to support growth of verification services as a center of excellence within USP. Responsibilities
Conducts thorough review and evaluation of quality control and manufacturing (QCM) documents and other data from manufacturers to ensure compliance with verification requirements. Prepares reports and communicates observations to participants to ensure corrective actions are taken where needed. Ensures compliance with verification procedures in the preparation of summary reports and approval letters for final disposition of verified products. Collaborates with verification staff, USP departments, contract auditors, and testing laboratories to coordinate work schedules for the verification programs. Conducts audits and coordinates with USP GMP auditors at USP Rockville and international sites to assist in thorough audits of program participants' facilities for drug substances, excipients, dietary ingredients, and dietary supplements. Performs surveillance activities to ensure audits and documentation reviews are conducted according to program requirements. Develops and revises standard operating procedures (SOPs) and participant manuals. Performs other duties as assigned. Education and Experience
M.Sc. degree in food science, analytical chemistry, biochemistry, or related fields. Minimum of five (5) years of relevant experience, or equivalent combination (e.g., B.S. with seven (7) years). Experience in cGMP facilities involved in manufacturing and/or QA/QC of foods, pharmaceuticals, and/or dietary supplements/ingredients. Industry Experience
Experience establishing quality systems compliance within the above fields. Willingness to travel approximately 10% domestically and internationally. Additional Desired Preferences
Extensive knowledge of FDA regulations pertaining to cGMP requirements. Knowledge of GMP audits using 21 CFR parts 111 and 117 is desirable. Regulatory interpretation, audit procedures, documentation, and Quality Assurance experience. ASQ Certified Quality Auditor (CQA) desirable. Familiarity with ICH guidelines and CTD for APIs; regulatory CMC submission experience is desirable. Analytical methodologies knowledge, good organizational and communication skills, detail oriented, and ability to handle multiple priorities. Project management experience is desirable. Third-party quality certification/verification experience is a plus but not required. Supervisory Responsibilities
None, this is an individual contributor role. Benefits
USP provides benefits including company-paid time off, comprehensive healthcare options, and retirement savings to protect your personal and family well-being. Compensation
Base Salary Range: USD $85,500.00 – $111,250.00 annually. Target Annual Bonus: varies by role. Individual packages are based on skills, experience, qualifications, equity, and other job-related factors. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities. This employer provides rights information pursuant to federal employment laws. See Know Your Rights from the Department of Labor at eeoc.gov. Job Category
Chemistry & Scientific Standards Job Type
Full-Time
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