Sr Product Complaint Specialist

Valeant Bridgewater , NJ 08807

Posted 3 months ago


  • Reviews and approves complaints for Pharmaceuticals, Cosmetics, and Nutritional products.

  • Monitors Complaint Records in the system to ensure that the standard process is being followed and complaints are closed as required.

  • Performs complaint classification and severity assessments as required.

  • Manages communication and follow-up of Critical complaints.

  • Collaborates with Consumer Affairs, Drug Safety, Internal affiliates, External sites, and other business partners to ensure appropriate complaint handling.

  • Takes an active role in issue complaint resolution activities and decisions within the complaint group and cross functionally.

  • Provides training as SME on the complaint process.

  • Develops and maintains Work Instructions, Job Aides and Training Materials.

  • Develops new procedures and revises existing procedures as required.

  • Facilitates and supports the Complaint Review Board meetings/process as required.

  • Escalates issues related to complaint trends, nonconforming product, etc.

  • Drives CAPAs related to complaint management. Conducts investigations into complaint trends to determine need for CAPAs or escalation.

  • Works with Manufacturers to improve timeliness and quality of complaint investigations.

  • Supports enhancements and upgrades to the Complaint System and performs User Acceptance Testing as required.

  • Leads/supports/implements complaint process improvement initiatives.

  • Provides Product Quality Complaints metrics/data/information as required.

  • Responds to ad hoc complaint requests for internal and external customers.

  • Provides direct support for internal/regulatory audits/inspections and responses to those audits/inspections.

  • Represents the Complaint Department on project teams, management meetings and internal/external forums.

  • Designee in the absence of the QA Manager, Product Complaints.

  • Other duties as assigned.


  • Bachelor of Science or equivalent required.

  • Expert knowledge of GMP Regulations and ISO guidelines

  • Ability to prepare written communications and communicate problems to management with clarity and accuracy.

  • Ability to understand safety, business (legal), and compliance risks related to complaints and in achieving performance objectives.

  • Ability to provide creative solutions to complex issues.

  • Delivers value-added business results through execution and controls.

  • Establishes good working relationships with colleagues and key stakeholders (internal and external).

  • Ability to write and review reports with clarity and brevity, and produce data reports with precision.

  • Good organizational skills a must. Effective communication skills needed to provide clear and concise information to team members.

  • Critical thinking skills and strong attention to detail.

  • Strong analytical and technical skills.

  • Demonstrate initiative and drive action and results.

  • Excellent writing and presentation skills.

  • Ability to plan, multi-task and manage time effectively.

  • Must be a self-starter, action oriented, customer-focused, problem solver, be able to work independently, and have the ability to multi-task under strict deadlines.

  • Strong Computer and Information Technology Skills (Windows, Word, Excel, Access, Power Point and Visio.)


  • 5-8 years' experience including Quality Assurance and/or Quality Control. Experience working in Pharmaceuticals, Medical Devices or other related or highly regulated industry required.

  • Previous product quality complaint handling experience required.

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Sr Product Complaint Specialist