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Quality Operations Specialist I

Princeton, NJ 08540

Posted: 05/02/2025 Employment Type: Contract Industry: Quality and Regulatory Affairs Job Number: 12138 Pay Rate: $30.00 - $32.00 Remote Friendly: Onsite

Job Description

Our client develops and commercializes therapies for hallucinations and delusions associated with Parkinson’s disease.


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.
  • 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.
  • 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.
  • 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.

Job Requirements

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.
  • 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.

Meet Your Recruiter

Lexie Pierce
Recruiter

As a Compass recruiter, Lexie brings in 15 years of experience in leadership and employee growth and development. She's incredibly passionate about helping candidates find and accept new opportunities, ultimately leading her to start her recruiting career in the life science industry. Her favorite part about connecting with Compass candidates and clients is witnessing the excitement the candidates exude and making an impact on their lives.

 

Outside of the office, Lexie enjoys going to the farmers' market on Saturdays with her son so she can find the best produce to use in her family dinners. She enjoys cooking, reading, knitting, restoring furniture, and spending time with her family and friends. Lexie is also passionate about supporting organizations that are looking to educate the community about Congenital Heart Defects (CHD).

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About Princeton, NJ

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