Quality Assurance for the PET CGMP Manufacturing Facility
This position is located in the NIH Clinical Center, PET CGMP Manufacturing Facility.
A full time GS-13 position is available in the NIH Positron Emission Tomography (PET) CGMP Manufacturing Facility, Clinical Center, NIH. As an integral quality team member, this individual will provide assurance that all products and quality system processes in the facility are in compliance with PET CGMP requirements (21 CFR part 212 and USP and currently in draft version) and NIH/Clinical Center policies and procedures.
We are looking for a highly motivated, flexible, proactive, resourceful and efficient candidate with working knowledge of CGMP regulations. A candidate with experience working in CGMP pharmaceutical manufacturing environment is highly preferred. The position requires the candidate to be flexible and have an adaptable style with an eagerness to take on challenges, be a problem solver who not only identifies issues but leads efforts to resolve them, and has strong leadership and motivational capabilities. The candidate must have excellent communication skills, both in writing and verbal and have excellent interpersonal skills.
This position involves but not limited to; authoring and reviewing SOP’s, maintaining controlled documents, review of logs and batch records, support quality event system investigations (e.g. deviations, out of specification, complaints, corrective and preventive actions etc.), coordinate material acceptance and management, manage change controls, support the environmental monitoring program, and be able to work on small or large scale projects individually or as part of a team. The candidate will perform quality assurance walk-through audits in addition to audit of data and processes, and have the ability to identify and analyze issues to develop relevant and realistic plans, programs and recommendations.
To apply to this position, please log onto usajobs.gov and apply to vacancy announcement NIH-CC-DH-19-10476406; please be sure to upload all requested documents. Applications can be submitted from May 14, 2019 to May 23, 2019. Salary is commensurate with experience.
This is a GS-13 federal appointment in the competitive service. A full benefits package (including retirement, health, life and long term care insurance, Thrift Savings Plan participation, etc.) is available. Appointees must be U.S. citizens.
Helpful resources on how to apply for this position and other Federal jobs, including what to include in your resume, can be found under the following link: https://www.usajobs.gov/Help/how-to/.
HHS and NIH are Equal Opportunity Employers. Selection for this position is based solely on merit, without discrimination for non-merit reasons such as race, color, religion, sex, national origin, politics, marital status, sexual orientation, physical or mental handicap, age or membership or non-membership in an employee organization. All applicants will be subject to a background investigation.
Telecommuting is allowed.
Additional Salary Information: Salary is commensurate with experience
Internal Number: NIH-CC-DH-19-10476406
Department of Health and Human Services
National Institutes of Health
Positron Emission Tomography (PET) Department
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