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.
To reinforce our team we are looking to fill the following position at our New Jersey site:
Quality Control Peer Reviewer (US)
The Quality Control Peer Reviewer performs all activities within Quality Control in compliance with Corporate Operating Procedures (COP), Standard Operating Procedures (SOP), Internal Operating Procedures (IOP), and Federal Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Occupational Safety and Health Administration (OSHA), and Environmental Protection Agency (EPA) requirements. They will also perform QC peer reviewing on all relevant records and analytical data in accordance with Operating Procedures (COP), Standard Operating Procedures (SOP), and Internal Operating Procedures (IOP). They will carry out the analytical review of QC analyses, LIMS authorization of analytical tests and QC release of raw materials, in-process controls, packaging materials, intermediates, and environmental tests.
- Coordinate with Materials Release Team Leader to ensure that raw data for all raw materials, intermediates, stability, and final release samples raw data are available on time in order to be reviewed and meet the scheduled deadlines for materials release;
- Consult with Peer Reviewer Team Leader or delegate in order to obtain work schedule.
- Review equipment, project, and general QC logbooks in addition to analytical data;
- Review analytical work related to equipment set-up, operational conditions in use and the execution of the analytical method;
- Review the preparation and expiry dates of reagents, standards, sample solutions and mobile phases (when applicable);
- Review and authorize results in LIMS;
- Perform QC release of raw materials, in-process controls, packaging materials, intermediates, and environmental tests;
- Propose changes for continuous improvement, either in safety, GMPs, or general QC efficiency;
- Communicate with management concerning all HSE issues and incidents, read posting of studies;
- Meet KPIs to establish goals as defined by management
- Bachelors of Science degree in Chemistry or related field, with 1-2 years minimum experience in analytical data review in a QC laboratory under GMP;
- Working knowledge of analytical theory, analytical investigations and techniques and familiarity with GMP procedures required for the laboratory work;
- Sense of ownership and pride in work;
- 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
- Competitve salary and benefits commensurate with the job function and candidate’s relevant experience;
- Excellent work environment, with a strong focus on quality and execution of top class science in state of the art equipment.