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 expanding and we are looking for strong professionals to join us and are currently recruiting for the following position:
Quality Control Analyst
The Quality Control Analyst ensures all Quality Control (QC) activities at the technical transfer center (TTC) are carried out 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.
The successful candidate provides high-quality support, duly integrated as defined in internal procedures, quality agreements and internal guidelines, in order to guarantee the requirements of clients, both internal and external. This position is responsible for contributing to the success of each project by meeting the requirements of the project team and supplying the necessary analytical chemistry know how in routine quality control analysis, technical transfer and/or validation of the analytical methods. Provide the analytical results and adequate pro-active interpretation to help enrich the team’s understanding of the project.
Follow the assignments from the Team Leader, on time and with quality.
Perform analytical testing (e.g. raw materials, intermediates, API, stability, cleaning, method validation and cleaning) in a timely manner to meet deadlines.
Execute qualification tests contained in protocols for equipment qualification.
Perform instrument calibrations on Balances, High Pressure Liquid Chromatography (HPLC), and Gas Chromatography (GC).
Carries out routine tasks, routine housekeeping related to the laboratory, and maintenance of analytical equipment.
Maintains equipment, project, and general QC logbooks.
Proposes changes for continuous improvement, either in safety, GMPs, or general QC efficiency.
Communicates with management concerning all EHS issues
Participates monthly GMP audits and weekly safety audits as delegated by QC Management.
Seek and sustain familiarization with hazard assessment (as carried out by the EHS officer) before working on a new project.
High school diploma with 5 to 8 years experience in a QC laboratory under GMP or Bachelor Degree in Chemisty or related Science degree with no minium QC laboratory under GMP experience requirement
Working knowledge of analytical theory and techniques and familiarity with GMP procedures required for the laboratory work.
Capable of analysis and reasoning
Sense of ownership and pride in work
Critical, detailed and organized
Self motivated, collaborative and team player
Able to work in fast pace environment and is adaptive to change
- 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.
If you wish to apply, please fill in the web application at Hovione Careers .
We will not accept applications by any other means.