Job Title: Quality Operations Specialist 
Duration:  06 Months
Location: Princeton, NJ 08540

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

• Tracking and closure of IR actions across multiple parallel workstreams, assist with meeting minutes, scheduling of meetings, trainings, etc.
• Manage updates to Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), Good Manufacturing Practices (GMP) SME Lists for Inspections
• 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

• Follow-up with teams with Spot Check responses due
• Follow-up on training due (based on PowerBI compliance metrics)
• Pull raw data from systems for metrics generation as requested

Other Quality Operations Support o Follow ups for process improvement program

• Budget/invoice tracking for QRC
• Tracking of new and revised controlled documents – follow ups with curricula owners on training changes, processing of Adobe Forms
• Scheduling of quality related training workshops
• Other internal meeting scheduling, minute taking, action item follow-ups as needed
• Other duties as assigned/required.

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/Experience/Skills:

• Bachelor’s degree in Science or a related field.An equivalent combination of relevant education and experience may be considered.
• 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.

 

 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $30.00/hr.