Quality Assurance Specialist II in Rockville, Maryland, United States

US Pharmacopeia
Type

Mid-level industry position

Quality Assurance Specialist II

Summary of the Position

QA Specialist II 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 of reference standards. The position also supports the USP Internal Audit 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 design, develop and implement new tools and techniques used in the overall Quality Systems at USP.

Roles and Responsibilities

  • Reviews/approves Reference Standard Candidate Evaluation Packages, Technical Data, and associated paperwork to ensure that all processes are appropriately documented

  • Participates in all Quality Management Systems programs, including investigations, CAPAs, Deviations, and Laboratory Investigations.

  • Participates in ISO 9001 certification and ISO 17025 accreditation activities as needed.

  • Provides global trending data and analysis of Quality Management System metrics (e.g., audit results, non-conformances related to product and performance, results of investigations, customer complaints etc.) on a quarterly basis in order to make recommendations on opportunities for improvement.

  • Conducts Internal Process/Target audits according to schedule

  • Participates effectively in cross-functional teams to maintain and improve the Reference Standards efforts on quality

  • Provides training in Quality concepts and tools, and design/develop training materials and instructional materials.

Basic Qualifications

  • Bachelor’s degree in either chemistry or biochemistry required.

  • Minimum of three (3) years of experience working in a quality control, wet chemistry, or analytical chemistry laboratory within the pharmaceutical industry.

Preferred Qualifications

  • 1-2 years relevant quality assurance experience

  • Effective in a variety of formal presentation settings; one-on-one, small and large groups with peers and superiors

  • Demonstrated skill in audit planning and auditing techniques

  • Previous CQA or lead auditor training is desired but not required

  • Demonstrated verbal and written communication skills including well-developed meeting facilitation skills

  • Ability to explain complex information simply to a diverse audience

  • Effective in a variety of formal presentation settings; one-on-one, small and large groups with peers and superiors

  • Individual must possess the ability to work well with diverse cultures and to influence without direct authority

Supervisory Responsibilities

Equal Opportunity/Affirmative Action Employer

USP is proud to be an equal opportunity/affirmative action employer. Employment selection and related decisions are made without regard to sex, gender identity, race, age, disability, religion, national origin, color, veteran status or any other protected class. We are committed to working with and providing reasonable accommodation to individuals with disabilities.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please send an e-mail to humanresources@usp.org or call (301) 230-3257 and/or 711 for TTD/TTY service.

3rd Party Recruitment Agencies

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.

Any unsolicited resumes sent to USP, including unsolicited resumes sent to a USP address, or email address, directly to USP employees, or to USP's resume database will be considered USP property. USP will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume. USP considers candidates for whom an agency has submitted an unsolicited resume to have been referred by the agency free of any charges or fees.

More Information

Type

Mid-level industry position

Rockville%2C%20United%20States

Rockville , United States