Hovione is an international company with over 55 years’ experience in the development and compliant manufacture of Active Pharmaceutical Ingredients and Drug Product Intermediates. With four FDA inspected sites in Portugal, the U.S., Ireland and China, Hovione offers integrated API, particle design, formulation development and GMP manufacturing. In the inhalation area, Hovione is the only independent company offering such a broad range of services.
Hovione New Jersey is installing innovative capacity for Continuous Manufacturing of Drug Product, capable of enhanced control strategy via Process Analytical Technologies and of Real Time Release testing.
To reinforce our team we are recruiting for strong indivduals to fill the following position at our U.S. site located in East Windsor, NJ:
Associate Quality Assurance Specialist
The Quality Assurance Associate Specialist promotes high quality standards and a continuous improvement culture within the Quality area of the New Jersey site in order to ensure that these are aligned with applicable quality regulations and the company's high quality standards. This role provides support in achieving the department objectives and supports the cGMP programs (i.e. validation, qualification, stability, and environmental control).
- Reviews completed batch records and associated deviations for final product release;
- Reviews executed protocols and other GMP related documentation;
- Handles client's quality related issues;
- Responsible for evaluation/approval of equipment cleaning;
- Follows-up periodically of ongoing deviations and change controls to assure timely closure of documentation;
- Prepares SOPs, quality related reports, and change control documents when appropriate;
- Reviews qualification/validation documentation;
- Reviews process validation protocols and reports;
- Provides support during Client audits/inspections;
- Follow-up periodically on client audits action plans and client complaints;
- Conduct regular inspections of the operational areas to verify compliance with cGMPs (i.e. internal audits);
- Identify deficiencies of the Quality System and pro-actively suggests/requests improvements;
- Promote the importance of high quality levels and the importance of a continuous improvement culture in all core company activities, and actively communicates with the various areas to identify areas for improvement;
- Provide cGMP training to staff and new team members;
- Acts as a catalyst for change and improvement in performance/quality;
- Preferably with a minimum of B.Sc. in Chemistry/Science of Chemical Engineering, or a minimum of 1-2 years of industrial operational experience working under cGMPs;
- Understanding of the cGMP requirements and knowledge of Quality by Design principles;
- Hands-on experience in writing and reviewing documentation for process and operations;.
- Critical, detailed, and organized;
- Self-motivated, collaborative and team player;
- Results driven, positive attitude, able to deal with multiple projects/tasks simultaneously;
- Demonstrates a high level of integrity at all times;
- Flexibility is essential (willingness to work shift patterns as required by business needs);
- Ability to work on own initiative;
- Excellent computer skills e.x. MS Word, Excel, Outlook;
- Pragmatic, resilient, proactive, creative, innovative and with high ethical standards;
- Exciting full time opportunity in a growing Company, using continuous manufacturing technology under a Quality by Design approach in an innovative setting.
- Competitive salary and benefits commensurate with the job function and candidate’s relevant experience.
- Great work environment, with a strong focus on quality and execution of top class science in state of the art equipment.