Quality Compliance Specialist IIApply Now Job ID 1603092 Date posted02/15/2017 LocationCambridge, Massachusetts, United States;
Product Complaint System Oversight:
Performs and/or coordinates the receipt, processing, monitoring and reporting of product complaints. Addresses and expedites product complaints under the company’s product complaint policy and procedures, and ensures compliance with federal regulations.
- Logs and maintains currency of product complaint documentation utilizing the product complaint tracking database.
- Coordinates the activities required to investigate and close Commercial product complaints, which includes following-up with Takeda’s contract call center and/or complainants, and facilitating cross functional product complaint sample inspections and analyses by applicable Takeda departments and Alliance Partners.
- Authors and sends Commercial complainant responses per established procedures and timelines.
- Monitors and analyzes product complaint data for trends, ensuring that appropriate corrective action plans are developed and routine status and trending reports are distributed to management.
- Escalates to management (as applicable), any identified risks, improvement opportunities and/or compliance concerns associated with the product complaint system. Provides suggestions to appropriate company authorities to modify existing manufacturing or packaging processes based upon pattern and related analyses.
- Co-facilitates periodic review meetings between Pharmacovigilance, Medical Affairs, Commercial Operations and Quality per Takeda procedures to ensure consistency of processing and reconciliation of product complaints and adverse events.
- May attend weekly Case Review Meetings (routinely) and Signaling Meetings (when applicable as backup), providing input on behalf of Commercial Quality Operations
Commercial Quality Operations:
Provides support for other Commercial quality operations as assigned.
- Interacts directly with internal customers at a peer level and with support personnel at suppliers.
- May provide training, as assigned, on department-specific procedures and systems.
- May provide subject matter expertise for the Quality Assurance group during internal, vendor and Alliance/Corporate Partner compliance or regulatory audits, when appropriate.
- May write, review, and some approvals of controlled documents.
- Collects data, calculates, & reports on performance metrics.
- Identifies and proposes process and system improvements.
- Supports Oncology and Biologics Quality in the timely implementation, assessment and closure of Commercial related projects and operations, as assigned.
- Assists to compile Annual Product Reviews for Takeda Commercial products.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Bachelor degree, 4+ years of biopharmaceutical experience
- Knowledge of cGMP regulations for US, EU and other markets
- Effective time management skills, detail oriented, organizational skills, teamwork and collaboration
- Strong computer, verbal and written communication skills
- Prior experience handling of commercial product complaint report investigations
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