Quality Assurance Specialist II (1181-679)

Location
Rockville, Maryland, United States
Posted
Sep 05, 2018
Closes
Oct 12, 2018
Function
IT, QA Engineer
Hours
Full Time

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.
  • Performs other related duties as required

 

Basic Qualifications 

  • Bachelor’s degree in a scientific discipline required or equivalent work experience
  • Minimum of three (3) years of relevant Quality Control (QC) lab or Analytical lab experience in a pharmaceutical, biotech or other regulated industry 

Preferred Qualifications 

  • Good understanding of ISO 9001,  ISO 17025, and some understanding of cGMPs
  • 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

None

 

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