Product Quality Complaint Investigator

Princeton, NJ

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Product Quality Complaint Investigator in Princeton, New Jersey.  The Product Quality Complaint Investigator role will manage the receiving and handling (documentation, coordination, investigation, resolution and closeout) of all Product Quality Complaints and patient-related field events in a manner that complies with regulatory requirements (21CFR Parts 210, 211, 820).  Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.

RESPONSIBILITIES

  • Manages Complaint Sample retrieval
  • Manages OPDC process pertaining to contact with healthcare professionals submitting product complaints
  • Reviews completed complaint files to assure proper documentation, coordination, investigation, resolution and closeout and ensure compliance to regulatory requirements as well as business requirements
  • Creates complaint, related CAPA trend analysis records and submit to management to ensure early detection of potential quality issues
  • Gathers data to assist with any potential recall and/or reporting actions
  • Monitors complaints for product trends and notify management of events requiring immediate action
  • Follow-ups with Sales Reps, Hospitals, Pharmacies and Physicians to obtain applicable information pertaining to reported events
  • Supports department continuous improvement activities in accordance with applicable regulations and business goals and objectives

EXPERIENCE

  • 2+ years of Product Complaint Quality Assurance experience in the pharmaceutical and/or medical device industry
  • Experience in analyzing product quality complaints and determining reportability to the FDA and other regulatory agencies
  • Strong knowledge of regulatory requirements (21 CFR Parts 210, 211, 820) specifically those applicable to complaint handling, investigations and documentation
  • Excellent analytical, problem solving, and troubleshooting skills
  • Proficient in MS Office software, Excel, TrackWise
  • Strong interpersonal and communication skills
  • Ability to work in a team environment
  • Ability to multi-task

EDUCATION

  • Bachelor’s Degree

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.  
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource. 

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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