The U.S. Pharmacopeial Convention (USP) Supervisor, Validation & Metrology in Rockville, Maryland
This is a key supervisory position within Central Laboratory Operations (CLO). The incumbent will lead a group tasked with responsibility of analytical instrument qualification (AIQ). This will include AIQ performed by vendors as well as those performed by in-house personnel. The incumbent will work closely with other CLO and laboratory staff in the overall lifecycle management of analytical instrumentation. The group’s tasks are to assist with instrument and procurement, coordinate vendor qualification schedules, perform on-site AIQ and calibration as needed, and to assist in on-site instrument repair assessments. The incumbent is expected to utilize scientific, computing, engineering, and other skills to continuously monitor and improve the laboratory equipment systems and keep them operational. The group will also work on technical problems related to analytical instrumentation to ensure the calibration, qualification, and state of validation is suitable for use by the various laboratories.
Roles and Responsibilities
Manage the Validation and Metrology staff members to carry out their tasks and responsibilities. Write group members’ goals and performance assessments and provide continuous feedback to improve performance and adherence to USP core values. Develop and mentor group staff members for potential growth and career advancement.
Schedule vendor visits for related services, and keep necessary lab personnel apprised.
Plan, schedule, and execute in-house qualification, calibration, preventative maintenance, and other validation and metrology activities.
Ensure that all laboratory equipment is properly installed, qualified, maintained and calibrated in accordance with ISO 9001 and 17025 guidelines.
Liaise with Facilities Dept. to ensure that laboratory facilities are properly functional, required utilities are available, and that proper environmental conditions are maintained in accordance with manufacturer recommendations.
Provide guidance on validation concepts to USP staff as needed.
Assists in the installation of laboratory equipment and maintains up-to-date inventories.
Assists various laboratories in lab capacity and annual budget planning, and in generating capital budgets.
Writes and revises Standard Operating Procedures (SOPs) for laboratory equipment operation. Writes issue reports for equipment and facilities related deviations and CAPAs.
Support the training of scientists on proper use, maintenance and care of the equipment.
Bachelor's degree in physical science or engineering, with a minimum of seven (7) years of relevant experience.
Experience in Pharmaceutical/Biotech industry desired.
Experience with ISO 9001 and 17025 guidelines, and/or cGMP quality programs required.
Excellent written and verbal communication skills required.
Previous supervisory experience
Strong analytical skills and ability to work on both basic and strategic processes.
Well-developed organizational, interpersonal, negotiation, and listening skills.
Able to operate independently, yet understands when to escalate issues and how to establish effective working relationships in a team setting.
Ability to lift 20 lbs and may be required to access spaces which require bending or kneeling positions.
Previous experience with Waters and Agilent liquid chromatography systems, and Waters Empower software.
Four direct reports
One Metrology Specialist
Three Validation and/or Instrumentation Engineers
USP offers an impressive benefits package, including:
Generous paid time off – 15 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.
The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP brings together more than 1,100 talented professionals across five global locations to deliver its mission to strengthen the supply of safe quality medicines and supplements 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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
Job Category Chemistry & Scientific Standards
Job Type Full-Time