Senior Quality Assurance Specialist (946-679)
This is a hands-on, non-supervisory, individual contributor position that supports the important work of USP’s Quality Assurance (QA) team. The incumbent will work independently, with some oversight, and will be primarily responsible for QA tasks related to the compendial development lifecycle (Documentary Standards). The incumbent anticipates and solves problems and issues within his/her area of responsibility. In addition, the incumbent designs, develops and implements new tools and techniques used in the overall Quality Systems at USP.
Roles and Responsibilities:
- Lead investigations resulting from the compendial development lifecycle, publications and information technology activities by conducting root cause analysis, risk assessment, corrective actions, follow-up to closure and effectiveness checks.
- Establish and maintain databases for tracking quality metrics. Analyze database information for trending and reporting purposes at pre-established frequencies.
- Execute the audit plan and provide robust audit reports within pre-established timeframes.
- Attend and participate in key cross-functional team meetings that are part of the compendial development lifecycle from early stages of development until it becomes part of the official compendia providing QA input as required.
- Prepare and support, as required, for certification to ISO 9001
- Provide support to management and be a resource to staff to achieve goals
- Provide internal and external department training as required
- Demonstrate use of quality improvement in daily work and operations and advocate for quality initiatives to other departments.
- Track project status for department. Create and distribute detailed project status reports to all staff in department to facilitate decision making about new project assignments.
- Apply knowledge of current trends in public health to the Compendial development lifecycle to facilitate decision-making.
- Bachelor’s degree in a science field and a minimum of 7 years of relevant Quality Assurance or Quality Control experience in pharmaceutical or other regulated industry. An equivalent combination of education and experience is acceptable
- Minimum of 3 years of cross-functional team experience
- Proficient in Excel, MS Word, Access, Power Point software applications at a minimum
- Must be a U.S. Citizen or Lawful Permanent Resident
- Master’s Degree in sciences is a plus.
- Advanced understanding of ISO 9001
- Knowledge of use of USP Compendia (Monographs, General Chapters)
- Knowledge of FDA regulations, other Compendia, and ICH guidelines
- Demonstrated skills in audit planning, reporting and lead auditing techniques with previous CQA or lead auditor training experience
- Ability to listen, interpret and influence without direct authority in a cooperative and friendly manner
- Detail oriented with well-developed organizational and prioritization skills
- Results and timeline driven with demonstrated successful outcomes.
- Ability to handle multiple priorities and shift priorities as a result of a fast-paced environment
- Well-developed presentation and meeting facilitation skills
- Demonstrated excellent verbal and written communication skills
- Ability to explain complex information simply to a diverse audience
- Experience in research and development, instrumentation techniques and analytical skills
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