Verification-GMP Auditor ( REMOTE)

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.

• 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 Prefere Team Lead, Senior Scientist II, Analytical Research & Development TEAML002551 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 for individuals with disabilities.

Brief Job Overview

This is a supervisory position in USP-India’s Analytical Research & Development Laboratory. In this role, the Senior scientist-II will work on isolation/ purification of known and unknown impurities/compounds by preparative HPLC and characterization of molecules using various analytical technique and Analytical Method Development for in process samples received from synthetic Lab. The successful candidate will also reviews/monitors isolation/ purification of known and unknown impurities, routine analytical tests, maintains safety & GLP environment in the lab including evaluation of reference standards, development/validation (as per requirement) of official methods, stability studies, and research projects in analytical department.

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 Sr. Scientist II Has The Following Responsibilities:

• [50%] Review the isolation/ purification of known and unknown impurities/compounds by preparative HPLC and Characterization of molecules using various analytical techniques and review sample analysis reports as per monograph / in-house procedures including reaction monitoring. Prepare development reports for Synthetic Support projects (USP-NF and PAI). Involve in project acceptance & approvals. Ensure the project's requirement by coordinating with the purchase department. Coordinate with lab scientists to complete ARD projects within timelines. Prepare/review lab reports and documents.
• [20%] Ensure that the calibrations of the equipment’s are performed as per the schedule.Prepare, Execute and complete IQ/OQ/PQ of new instruments. Indent the required glass wear chemicals, and columns for the ARD projects. Maintain GLP & implement safety procedures.while working in Lab. Perform additional Projects/activities as per the requirement. Work inopen access instruments to support a team of synthetic scientist and deliver result in a timely manner. Support the synthetic R&D projects.
• [20%] Assist in the development and implementation of safety projects impacting all USP Laboratory personnel. Participates in USP cross-functional teams as appropriate. Develop Standard Operating Procedures and policies in ARD Lab. Coordinate with Quality Assurance staff to ensure the implementation of corrective actions. Responsible for internal, method, ISO-9001 & ISO-17025 audits
• [10%] Promote Diversity, Equity, Inclusion, and Belonging principles at USP India.
  
  

Who is USP Looking For?

Example:

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:

• MSc. in Analytical Chemistry / Organic Chemistry/M. Pharm, having 13-15 years' experience in Analytical Research and Development or Ph.D. with 10-13 years of experience in Analytical Research and Development
• Must have hands on experience in working with chemical methods and handling instruments like Prep HPLC and HPLC. Expertise in HPLC & Prep HPLC method development and basic undersatnding in data interpretation of various analytical technique such as LCMS, GCMS, FTIR, UV-Visible, NMR etc is required.
• Experience in analytical testing and development with focus on process analytical chemistry. Exposure to GMP/GLP environment and documentation procedures required.
• A comprehensive understanding of the science involved in the development of synthetic organic molecules and analytical chemistry.
• Must be able to communicate effectively with both internal and external customers. Preferably familiar with electronic notebook documentation of experimental procedures.
• Must possess a strong work ethic and a solid record of problem solving and technical results.
• Excellent technical writing and verbal communication skills are required.
• Good interpersonal skills and proven ability to function in a team-oriented environment are necessary. Proven self-effectiveness skills are a must. Understanding of GMP / ISO-IEC 17025 Guidelines is a requirement
  
  

Additional Desired Preferences

• Knowledge of handling , XRD, TGA, DSC, IC and ICP-MS will be an added advantage.
• General chapter information, ELN, Empower and NuGenesis will be an added advantage.
• Skilled in evaluation and interpretation of data; Ability to multi-task.
• Skilled in anticipating, troubleshooting, and solving technical problems.
• Takes personal responsibility to ensure work is delivered on time and is of the highest quality.
  
  

Desired preferences are to showcase any additional preferred levels of expertise to perform the role. Reminder: any items listed in this section are not requirements nor disqualifies for candidate consideration.

Supervisory Responsibilities

Three direct reports.

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.

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.

Job Category Chemistry & Scientific Standards

Job Type Full-Time