Luitpold Pharmaceuticals, Inc. Quality Assurance Investigation Specialist - Shirley, NY in Shirley, New York

Luitpold Pharmaceuticals, Inc.

Luitpold Pharmaceuticals, Inc., a Daiichi Sankyo Group Company, is dedicated to the development and marketing of innovative, quality drugs and medical devices for healthcare professionals, clinics, and hospitals across the United States and Canada. We specialize in sterile injectables, bone regeneration materials for dental procedures, as well as innovative products for veterinary medicine use.

The Quality Assurance Specialist writes investigations to resolve questions or issues regarding the aseptic or sterile filling manufacturing process. They are responsible for assisting in the resolution of quality related issues by gathering relevant and factual information. They assist in the investigation process to assure products conform to established requirements and standard through appropriate audit and inspection activities.

Essential Duties and Responsibilities

  • Draft and facilitate the resolution of deviations and complaint investigations as necessary. Review investigation documents to ensure mitigation of product impact. Schedule initial follow-up meetings in response to critical investigations.

  • Train new technical writers on the investigation process and the details required to support an investigation and mitigate product impact issues.

  • Drill down and appropriately document Root Cause Analysis for all deviations.

  • Generate and present weekly and monthly metric reports for QA Management.

  • Participate in technical projects and review of ancillary documents including work orders and document revisions, as needed.

  • Identify quality process improvements to increase efficiencies and performance of systems, operations and personnel.

  • Identify and resolve objectionable GMP issues which may impact product quality and escalate the issues to senior management in a timely manner.

  • Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as GMP and health and safety requirements in the markets where product is sold.

Qualifications and Requirements

  • Associate's or Bachelor's degree in a science-related field is required. Engineering or equivalent experience is preferred.

  • 3-5 years in a pharmaceutical setting

  • Experience working in a GMP/FDA regulated environment is a must

  • Must be results-oriented, able to make decisions independently, and able to prioritize work per business needs

  • Strong organizational and time management skills are necessary

  • Strong technical writing skills required

  • Ability to work flexible hours when needed to support lot releases

We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Job Title: Quality Assurance Investigation Specialist - Shirley, NY

Employment Type: Full Time

Classification: B

Date Posted: 07/21/2017

Requisition ID: 1751