Senior Verification GMP Auditor REMOTE

Who is USP

The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds top authorities in health and science to develop quality standards for medicines dietary supplements and food ingredients. USPs fundamental belief that Equity Excellence manifests in our core value of Passion for Quality through our more than 1300 hardworking 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 workan 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 Senior Verification GMP Auditor is a nonsupervisory position and handson 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

Remote employees must reside in one of the following states: MD VA DC PA WV CA MI IL KS FL NC or MN.

How will YOU create impact here at USP

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.

The incumbent 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 USPs objectives and the needs of the verification programs participating companies in order to support continued growth of the verification services as a center of excellence within USPs fastpaced rapidly changing organization.

Specific responsibilities include:

• Reviews the initial audit information submitted by participants and assesses the participants 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 sites 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:

• Masters degree in Science with minimum of seven 7 years or
• Bachelors degreewith minimum of nine 9 years of relevant experience in food science microbiology chemistry biochemistry or other related fields working as a GMP auditor in current Good Manufacturing Practice (cGMP) facilities engaged in the manufacturer and/or quality control of foods 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.
• Knowledge of and experiences with GMP audits using 21 CFR parts 111 and 117 are required.
• Certificate from the American Society for Quality (ASQ) as a Certified Quality Auditor (CQA) is required.

Additional Desired Preferences

• Extensive knowledge of FDA regulations pertaining to cGMP requirements.
• Proficient with regulation and guideline interpretation audit procedures proper documentation and Quality Assurance.
• 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.
• Thirdparty 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 this is an individual contributor role.

Benefits

USP provides the benefits to protect yourself and your family today and tomorrow. From companypaid time off and comprehensive healthcare options to retirement savings you can have peace of mind that your personal and financial wellbeing is protected.

Compensation
Base Salary Range: USD $00 annually.
Target Annual Bonus: Varies based on level of role.
Individual compensation packages are based on various factors unique to each candidates skill set experience qualifications equity and other jobrelated 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.

Required Experience:

Director