What are the responsibilities and job description for the Quality Engineer position at Katalyst HealthCares & Life Sciences?
Responsibilities
- Provide technical expertise in conducting investigations and making recommendations for targeted data and information collection as required for quality events.
- Collaborate with cross-functional production support teams to identify root cause and determine appropriate corrective action/preventative actions for investigations.
- Resolve unique and/or adverse situations, gather and review information from diverse functional areas, and make appropriate quality recommendations based on evidence.
- Review and approve protocols, validation documents, investigations and procedures.
- Approve change controls and represent Quality in Change Control Board meetings as needed.
- Provide Quality on the floor presence in support of manufacturing operations.
- Represent QA in a range of internal team meetings, processes and initiatives.
- Alert management of critical issues that have significant impact to manufacturing objectives and timelines, while providing a range of achievable solutions.
- Actively promotes safety rules and awareness. Always demonstrates good safety practices including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
- Actively demonstrates the values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.
- BS/BA degree in a scientific discipline with 2 years of progressive experience in the pharmaceutical or radiopharmaceutical industry or related GMP environment, or equivalent.
- Must Haves 3-5 years exp with fill finish, quality events, capa, change controls, on the floor batch records, aseptic exp.
- This position is site-based and requires a presence on-site five days per week.
- Aseptic fill-finish experience, including familiarity with validation of aseptic manufacturing technologies and facilities is preferred.
- Routinely scheduled work, and/or work required on evenings, weekends, and or holidays and, even in adverse weather conditions to support manufacturing operations. See Essential Personnel Policy.
- Handling of and, or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures and use personal and protective equipment provided.
