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Quality Operations Specialist I
502 Carnegie Center Drive, Suite 300, R&D Center Princeton, NJ 08540 US
Job Description
*Depending on experience
Position Summary: Responsible for assigned operational Quality Risk and Compliance (QRC) activities supporting Research and Development (R&D) quality efforts, including support of inspection readiness (IR), process improvement, quality metrics, and other assigned duties. Candidate will be required to work closely with internal R&D teams across all departments such as Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Drug Safety and Pharmacovigilance, Translational Sciences, Program Management, and Medical Affairs. Primary Duties and Responsibilities: • Inspection Readiness(IR) Support o Tracking and closure of IR actions across multiple parallel workstreams, assist with meeting minutes, scheduling of meetings, trainings, etc. o Manage updates to Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), Good Manufacturing Practices (GMP) SME Lists for Inspections o Follow-up on mock inspection Corrective and Preventive Actions (CAPA) closure and completion of lessons learned • Quality Metrics Support o Follow-up with study teams on metrics responses o Follow-up with teams with Spot Check responses due o Follow-up on training due (based on PowerBI compliance metrics) o Pull raw data from systems for metrics generation as requested • Other Quality Operations Support o Follow ups for process improvement program o Budget/invoice tracking for QRC o Tracking of new and revised controlled documents – follow ups with curricula owners on training changes, processing of Adobe Forms o Scheduling of quality related training workshops o Other internal meeting scheduling, minute taking, action item follow-ups as needed o Other duties as assigned/required.
Skills:
Must possess: • Excellent communication skills, both verbal and written. • Able to work independently as well as in cross-functional teams. • Excellent pro-active, interpersonal, problem-solving, conflict resolving skills. • Flexibility to switch between projects and assignments; ability to manage multiple projects, work streams and activities on a daily basis. • Able to gain cooperation of others. • Proficient computer skills, including Microsoft Word, PowerPoint and Excel. Power BI experience a plus
Education:
Education/Experience/Skills: Bachelor’s degree in Science or a related field. Targeting 1-3 years of progressively responsible experience within the pharmaceutical or biotech industry, including 1 year in Quality and/or Clinical Operations or other R&D function. An equivalent combination of relevant education and experience may be considered.
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Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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