Job Summary
We are seeking a Quality Assurance Specialist - Instrumentation and Systems to support our Quality team.
About the Role
* This is an exciting opportunity for a highly motivated individual to join our team as a Quality Assurance Specialist - Instrumentation and Systems, providing technical expertise in instrumentation and systems to ensure compliance with quality standards and regulatory requirements.
* The successful candidate will be responsible for supporting the development, implementation, and maintenance of quality procedures related to instrumentation and systems, ensuring that all equipment is properly qualified and calibrated, and that all data generated is accurate and reliable.
* You will also be involved in the investigation and resolution of instrument-related issues, as well as providing training and guidance to colleagues on quality-related matters.
* In addition, you will contribute to the development and review of SOPs, trend reports, risk assessments, laboratory investigations, and change controls.
* Your role will also involve participating in internal audits and inspections, as well as ensuring that laboratory logbooks and notebooks are maintained to GLP standard.
Key Responsibilities
* Support the development, implementation, and maintenance of quality procedures related to instrumentation and systems.
* Ensure that all equipment is properly qualified and calibrated, and that all data generated is accurate and reliable.
* Investigate and resolve instrument-related issues.
* Provide training and guidance to colleagues on quality-related matters.
* Contribute to the development and review of SOPs, trend reports, risk assessments, laboratory investigations, and change controls.
* Participate in internal audits and inspections.
* Maintain laboratory logbooks and notebooks to GLP standard.
Requirements
* Technical writing assignments including SOPs, trend reports, risk assessments, laboratory
investigations, and change controls.
* Displays competency in the following technical areas: HPLC, IR, UV, dissolution physical testing etc.
* Excellent communication and interpersonal skills.
* Ability to work independently and as part of a team.
* Highly organized and detail-oriented with excellent time management skills.