Senior Associate, Quality Assurance

US-NJ-Jersey City
Job ID
2017-1050
# of Openings
2
Category
Quality Assurance

Overview

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma America, Inc. (MTPA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

 

With the recent FDA approval and availability in the U.S. of RADICAVA™ (edaravone), MTPA is rapidly expanding our operation across all functional areas to launch this new product in the U.S. market. Concurrently, the company is expanding its research efforts and exploring collaborations with partners to discover and bring treatments to market for unmet medical needs including orphan diseases. We currently seek motivated professionals who share our vision of scientific excellence, innovation, and unwavering dedication to improving the lives of patients.

 

The Senior Associate, Quality Assurance is responsible for supporting all aspects of Quality Assurance (QA) and Compliance related day-to-day operational activities with a specific focus on QA documentation (e.g., change control documents, quality complaints, training records, monthly reports/scorecards, etc.), investigations, audits and other ad hoc cross-category initiatives.

Responsibilities

  • Reviews product batch records to identify and resolve atypical occurrences.
  • Prepares, reviews and/or maintains a range of other QA documentation as required (e.g., annual product review reports, change control logbooks, training records, quality data binders, directories, databases, etc.).
  • Ensures documents are completed, signed, and date stamped prior to filing or uploading to databases in accordance with MTPA quality systems SOPs.
  • Assists the Director, QA by initiating, assisting with and/or reviewing quality product complaint investigations, regulatory and corporate inspections, non-conformance investigations, Corrective and Preventive Actions (CAPA), and extension requests.
  • Liaises with service providers, MT Pharma Corporate QA and functional stakeholders on a range of QA activities.
  • Requests and/or provides documents as needed to support regulatory filing requirements.
  • Assists in creating training materials for QA SOPs, CGMP (Compliance with Good Manufacturing Practices); demonstrates adherence and compliance as a model for other colleagues to follow.
  • Evaluates and enhances departmental and company and/or vendor site quality procedures to ensure compliance with CGMPs and company policies; communicates any compliance issues to QA Director as they arise.
  • Prepares yearly audit schedule; performs audit preparation activities for supplier, regulatory, and corporate CGMP audits.
  • Prepares, maintains and distributes, as appropriate, monthly reports, quality trend analysis/quality scorecards, trending charts, and meeting minutes.
  • Maintains and keeps track of audit files, SOPs, product disposition documents, non-conformance investigations, extension requests, and CAPA.
  • Participates on project teams or on-site meetings as directed by QA Director.
  • Cross-trains departmental and/or cross-functional employees to act as a back-up for departmental activities.
  • Assists in vendor qualification process. Interacts with vendors, obtains qualification related documents, facilitates the completion of vendor surveys, performs vendor risk analysis and audits, and writes audit reports.
  • Manages within allocated budgets and resources as appropriate.
  • Performs other duties as required.

Qualifications

  • Bachelor’s degree, preferably in chemistry, biology, pharmacy or related scientific discipline
  • Minimum of 2 - 4 years QC/QA experience in a CGMP pharmaceutical environment encompassing change controls, training, complaints, audits, nonconformance investigations, CAPA documents and data management
  • Experience working with service providers and in a matrix organization
  • Experience working with paper and electronic based documentation
  • Experience in preparation of quality score cards and monthly departmental reports
  • Experience in parenteral manufacturing is preferred but not required
  • Understanding of pharmaceutical drug product development and manufacturing
  • Ability to work independently with limited supervision
  • Knowledge of US FDA CGMPs and other regulatory guidance
  • Excellent interpersonal, communication and technical writing skills
  • Proficiency with computer programs such as Excel, Access, PowerPoint, SAP, ISO-Train, Track-Wise or other similar computer databases

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