Quality Assurance Specialist II (957-679)
This is a hands-on, non-supervisory position that supports the important work of USP’s Quality Assurance team. The incumbent’s primary responsibility is the review of records for the qualification and/or production of reference standards. The position also supports the USP Internal and Supplier Evaluation programs and the investigation of incidents and non-conformances. The incumbent anticipates and solves problems and issues within his/her area of responsibility. In addition, the incumbent helps to develop and implement new tools and techniques used in the overall Quality Systems at USP.
Roles and Responsibilities
- Review/Approve Master Production/Label Batch records and Project Audits from the laboratories
- Review executed production batch records and associated paperwork to ensure all processes are appropriately documented and release of final finished product to Distribution
- Ensure that QC/Acceptance testing is completed per applicable SOPs
- Conduct Facility inspections and Method audits according to schedule
- Conduct/Lead Internal Process audits according to schedule
- Support Supplier Evaluation Program, conduct Supplier Evaluation Audits
- Lead/support Process Improvement teams or initiatives
- Provide training in Quality concepts and tools, and design/develop training materials and instructional materials.
- Participate in all Quality Management Systems programs, including investigations, CAPAs, Deviations, and Laboratory Investigations
- Track and trend data to support quarterly quality metric reports
- Performs other related duties as required
- Model USP values in all aspects of work performance and interactions
- BS degree and 5 years of relevant quality assurance experience in a pharmaceutical, biotech, or other regulated industry. An equivalent combination of education and experience is acceptable
- Auditing experience required
- Solid understanding of ISO 9001, ISO 17025 and some understanding of cGMPs
- Meeting facilitation skills
- Demonstrated skill in audit planning and auditing techniques
- Previous CQA or lead auditor training
- Demonstrated interpersonal, verbal and written communication skills
- Ability to explain complex information simply to a diverse audience
- Highly motivated, self-directed and the ability to work independently
- Ability to carry out tasks in a timely manner
- Ability to prioritize, manage time well, multitask and troubleshoot
- Ability to work as a team member, maintaining day to day activities while being responsive to changing priorities
- Demonstrated leadership potential
USP offers an impressive benefits package, including:
- Generous paid time off – 13 paid holidays, 10 sick days and 15 vacation days per year to start
- An annual 401(k) contribution, beginning after 1 year of service, of 10% of pay (base and bonus) every pay period that vests immediately
- Comprehensive individual and family healthcare plans with affordable premiums and low annual deductibles ($250/individual or $500/family)
The U.S. Pharmacopeial Convention (USP) is a scientific nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide. USP’s drug standards are enforceable in the United States by the Food and Drug Administration, and these standards are used in more than 140 countries.
Being a part of USP means belonging to a diverse culture made up of more than 1,000 talented professionals working together at five international locations. We share our expertise in science, IT, human resources, quality assurance, communications, administrative management, and more...all to support an overall mission dedicated to making a difference by providing standards and programs that help improve the quality of medicines, dietary supplements, and foods worldwide.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. Employment selection and related decisions are made without regard to sex, race, age, disability, religion, national origin, color, veteran status, sexual orientation, gender identity or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
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.Job Location Rockville, Maryland, United States Position Type Full-Time/Regular