Quality Assurance Specialist

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

QA Specialist is a handson nonsupervisory position that supports USPs Quality Assurance team. The incumbents primary responsibility is the review of records for the qualification of reference standards. The position also supports the USP Internal Audit programs and the investigation of incidents and nonconformances. The incumbent anticipates and solves problems and issues within his/her area of responsibility. In addition the incumbent helps/colead to design develop and implement new tools and techniques used in the overall Quality Systems at USP.

How will YOU create impact here at USP

• Quality Systems:

• • Support the development implementation and monitoring of Quality programs policies and procedures to ensure compliance with certifications/accreditations requirements corporate policies and procedures.
  • Support the Supplier Quality Management program by conducting supplier evaluations audits and supplier performance/metrics.
  • Review/approve the following:

1. Equipment IQ/OQ/PQ documents
2. Equipment calibration documents
3. Qualityrelated issues complaints deviations and investigations with appropriate corrective/preventive actions.
4. Review/approval of technical and analytical documents of moderate to high complexity for Reference Standards and/or Analytical Reference Materials (ARM)
5. Method validation reports
6. Batch Records
7. Lab data projects

• Lead internal process/target audits according to a predefined schedule.
• Track and trend different elements of the quality system and report on the progress of the programs including areas of strength and opportunities for improvement on a regular basis.
• Drive continuous improvement initiatives across the organization utilizing quality methodologies to optimize processes and enhance efficiencies.

• ISO 9001/17025: Participates in ISO 9001 ISO 17025 and other certification/accreditation activities.
• Performs other duties as required.

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 area (Chemistry Pharmacy Biology) and a combination of skills and experience in the pharmaceutical or related industry preferably working in Development QA/Analytical Reviewer role/Quality Assurance in API or formulations.
• A minimum of 810 years of experience in Quality including developing and implementing a Quality Management System.
• Minimum of three 3 years of handson experience in laboratory handling of analytical equipment qualification of analytical equipment calibration metrology and other laboratory activities is preffered.
• Knowledge on Analytical Method validations related testing is an added advantage.
• Must have successful experience with ISO 9001/17025 and/or GMP.
• Strong written and verbal communication skills including welldeveloped interpersonal skills used to influence the behavior of others and the ability to provide candid feedback at all levels.
• Proficiency in conflict negotiation and resolution; ability to influence across disciplines and at all levels.
• Ability to prioritize manage time well multitask and troubleshoot.
• Working knowledge of MS Word PowerPoint Excel etc.

Additional Desired Preferences

• Strong leadership capabilities in a dynamic business environment.
• Highly motivated selfdirected and have the ability to work independently while handling multiple tasks.
• Demonstrated ability to build strong credible working relationships across the organization and to communicate and interface with customers third parties and diverse audiences at all levels of the organization.
• Demonstrated ability to identify areas of potential quality nonconformance independently and successfully and to apply process acumen to resolve operational issues identify gaps reduce exposures and assure conformance.
• Ability to structure an issue and analyze alternative and creative solutions using metrics good analytical skills risk level and other data and methods to evaluate data and trends for lessons learned required action etc.
• Solid independent thinking ability and demonstrated ability to discern multiple viewpoints.
• Proven ability to raise and resolve issues when others are directly accountable for outcomes.

Capability of uniting different elements to achieve a singular goal creating strategies and policies and altering company operations to succeed..

Supervisory Responsibilities

None.

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.

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

Required Experience:

Unclear Seniority