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:
QC Analyst - Drug Product (US)
The Quality Control Analyst (Drug Product) will support drug product manufacturing, and as such should demonstrate experience in powders, tablets, and other drug product analytics.
The Quality Control Analyst ensures all Quality Control (QC) activities at Hovione LLC 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 knowledge in routine quality control analysis, technical transfer and/or validation of the analytical methods.
- Follow the assignments from the Team Leader, on time with quality;
- Perform analytical testing (i.e. 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 HSE 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 HSE officer) before working on a new project;
- High School diploma with 5 to 8 years of experience in a QC laboratory under GMP or Bachelor degree in Chemistry or related Science degree with no minimum QC laboratory under GMP experience requirement;
- Working knowledge of analytical theory and techniques (GC, HPLC) and familiarity with GMP procedures required for the laboratory work;
- Working knowledge of analytical methods for drug product;
- A good knowledge of wet chemistry, Karl Fischer, FTIR, particle size analysis;
- Capable of analysis and reasoning
- Sense of ownership and pride in work;
- Critical, detailed and organized;
- Self-motivated, positive attitude, collaborative and team player;
- Having international experience is a plus;
- Pragmatic, resilient, proactive, creative, innovative and with high ethical standards;
- Able to work in a 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
- Competitve salary and benefits commensurate with the job function and candidate’s relevant experience;
- Excellent work environment, with a strong focus on quality.