Quality Operations Specialist Position Available In Mercer, New Jersey

Job Description 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. Applicant Notices & Disclaimers
For information on benefits, equal opportunity employment, and location-specific applicant notices, click here 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.