Supervisor, Operation Compliance (893-679)

Location
Rockville, Maryland, United States
Posted
May 26, 2017
Closes
Jul 01, 2017
Function
Management
Hours
Full Time

This is a key hands-on and supervisory position in the Central Laboratory Operations (CLO) department responsible for several aspects of operations and compliance at USP laboratories located in Rockville and Frederick, MD.  Additionally, coordination with stakeholders at international partner sites will be critical in some operational areas.  The incumbent will recommend, implement, and track improvements in operational processes affecting quality, compliance, training and other parameters.  The incumbent will also be responsible for supervising individuals in CLO that support the operations of laboratories at USP, Rockville.

Roles and Responsibilities:

  • Supervise and lead individuals in the group that support laboratory activities.
  • Set group priorities and goals and hold employees accountable for results.
  • Ensure US based laboratories are executing processes and practices that adhere to quality policies as set forth by the Quality Assurance Department, and are compliant with ISO 9001 and 17025 requirements.
  • Actively participate in the preparation and conduct of ISO 9001 and 17025 audits, as well as internal QA audits.
  • Perform internal audits and gap analyses of CLO and other US laboratories to keep proactive on issues, identify deficiencies, propose improvements, and take necessary corrective actions.
  • Investigate, evaluate, and recommend process improvements that affect quality, compliance, training and other key aspects of CLO and laboratory operations.
  • Monitor and track key laboratory performance parameters, such as quality metrics, SOP revisions, and training effectiveness.
  • Monitor Laboratory Investigations, Issues, Deviations, and CAPAs to ensure closure.
  • Deliver quality related training in a variety of meeting formats (individual, group, or department).
  • Implement new procedures to continuously improve existing processes in CLO and other laboratories.
  • Create and/or revise Standard Operating Procedures (SOPs) for CLO and laboratory operations.
  • Create and/or assist on reports for CLO and laboratory related deviations and CAPAs.
  • Supports multiple laboratories as needed.
  • Performs other related duties as assigned.

 

Basic Qualifications 

  • Bachelor’s degree in life science, physical science, engineering or relevant field.
  • Minimum of eight (8) years of experience with ISO 9001 and 17025 guidelines, or cGMP quality programs.
  • Minimum of five (5) years of experience in a Pharmaceutical/Biotech based industry
  • Minimum of three (3) years supervising or managing direct reports within an organization.

 

Preferred Qualifications 

  • Prior experience managing programs provided through vendor support.
  • Excellent written and verbal communications skills.
  • Strong analytical skills and ability to work on both basic and strategic processes.
  • Experienced in foreseeing potential issues, investigating outcomes, and negotiating successful resolutions.
  • Results driven with demonstrated successful outcomes.
  • Ability to operate independently and handle multiple priorities in a fast-paced environment.
  • Able to work flexible hours on occasion with advance notice.
  • Ability to influence decisions without direct authority.
  • Ability and desire to work well with diverse employees in a cooperative and friendly manner.
  • Ability to lift 20 pounds and access spaces which require bending or kneeling positions.

 

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