Verification-GMP Auditor ( REMOTE)
Rockville, MD
| Employer: | US Pharmacopeia |
| Category: | Information Technology |
| Job Type: | Full Time |
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Description Who is USP? The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's top authorities in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for Quality through our more than 1,300 hard-working professionals across twenty global locations to deliver the mission to strengthen the supply of safe, quality medicines and supplements worldwide. At USP, we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create, the partnerships we build, and the conversations we foster, we affirm the value of Diversity, Equity, Inclusion, and Belonging in building a world where everyone can be confident of quality in health and healthcare. USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our work—an environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abilities, education, religion, gender identity, and expression, life experience, sexual orientation, country of origin, regional differences, work experience, and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities. Brief Job Overview This is a non-supervisory position and hands-on, technical position responsible for conducting onsite Good Manufacturing Practice (GMP) facility audits and reviewing ingredient and dietary supplement quality control manufacturing (QCM) documentation for products submitted into the USP Verification Program. How will YOU create impact here at USP? In this role at USP, you contribute to USP's public health mission of increasing equitable access to high quality, safe medicine and improving global health through public standards and related programs. In addition, as part of our commitment to our employees, Global, People, and Culture, in partnership with the Equity Office, regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments. The incumbent will serve as a GMP auditor as well as the primary and/or secondary contact for participants in the verification program(s) and will manage verification projects, working closely with participating companies and with fellow staff throughout the verification process to ensure timely completion of work. They will be responsible for the preparation and/or evaluation of cGMP site audits/reports, QCM documentation/reports, and test data/results regarding facilities and products undergoing verification. In addition, you will help develop and implement new tools, procedures, and techniques for the verification department to meet USP’s objectives and the needs of the verification program’s participating companies in order to support continued growth of the verification services as a center of excellence within USP’s fast-paced, rapidly changing organization. The GMP Auditor has the following responsibilities: • Reviews the initial audit information submitted by participants and assesses the participant’s readiness for a formal audit. • Conducts GMP site audits of manufacturing facilities for dietary supplements, active pharmaceutical ingredients (API), excipients, and dietary ingredients, according to the appropriate GMP guidelines and program requirements. • Prepares audit reports in a timely manner summarizing the results of the site audits and make assessments regarding the site’s compliance with GMP requirements. • Collaborates with USP GMP auditors at both the Rockville location and international sites, offering essential support to ensure auditors can thoroughly audit the manufacturing facilities of program participants, which produce drug substances, excipients, dietary ingredients, and/or dietary supplements. • Performs detailed reviews and evaluations of QCM (quality control and manufacturing) documents and other data received from pharmaceutical, ingredient and dietary supplement manufacturers to ensure compliance with verification requirements. Prepares reports based on observations made during the review and corresponds with program participants to ensure acceptable corrective actions are implemented. • Ensures compliance with verification procedures and requirements in the preparation of summary reports and approval letters for the final disposition of products undergoing verification. • Works collaboratively with all parties to create a work schedule with verification staff, other USP departments, contract auditors, and testing laboratories on matters relating to the verification programs. • Conducts surveillance activities for participants to ensure that surveillance audits/internal audits and surveillance documentation review and product testing are conducted according to program requirements. • Develops and revises standard operating procedures (SOPs) and participant manuals. • Performs other duties as assigned. Who is USP Looking For? The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: • Master’s degree in Analytical chemistry, Biochemistry or other related fields with minimum of five (5) years of relevant experience or equivalent combination of education and experience. OR Bachelor’s degree and seven (7) years of relevant experience or equivalent combination of education and experience. o Relevant experience working as a GMP auditor in current Good Manufacturing Practice (cGMP) facilities engaged in the manufacturer and/or quality control of pharmaceuticals and/or dietary supplements. • The incumbent should have industry auditing experience in the establishment of quality systems compliance within the above field(s). The incumbent must be willing to travel approximately 25 % domestically and internationally. Additional Desired Preferences Knowledge of and experiences with GMP audits using 21 CFR parts 111 and 117 are required. • Extensive knowledge of FDA regulations pertaining to cGMP requirements. • Proficient with regulation and guideline interpretation, audit procedures, proper documentation, and Quality Assurance. • Certificate from the American Society for Quality (ASQ) as a Certified Quality Auditor (CQA) is required. • Working knowledge of the International Conference on Harmonization (ICH) quality guidelines and multidisciplinary guideline on the Common Technical Document (CTD) for APIs is desirable. • Good organizational, planning, and excellent verbal and written communication skills. • Detail oriented; able to deal with multiple changing priorities; and able to work with minimal supervision. • Effective and efficient project management experience is desirable. • Third-party quality certification/verification experience in the pharmaceutical or dietary ingredient/supplement industry is a plus, but not required. • Ability to work remotely with minimum supervision and travel to clients’ manufacturing sites (California resident preferred, but not required). Supervisory Responsibilities None. Individual Contributor Benefits USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. Target Annual Bonus: 10% Varies based on level of role Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related reasons. Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c) Job Category Technical Programs Job Type Full-Time | |