[ Back ] [ The Roadtechs Medical / Pharmaceutical Job Board ] [ Help ] [Edit ] [Mark Position Closed ]
Seeking an associate to support team members in the planning, coordination, execution and documentation of the QC equipment lifecycle. The person is also responsible for equipment qualification and maintenance records. The successful candidate who has demonstrated outstanding performance will have priority to be considered for regular employee hiring should a position open
Job Duties/Responsibilities: Provide support to team members in the planning, coordination, execution and documentation of QC equipment lifecycle in compliance with GMP requirements. Progressing to generation of User Requirement Specifications, System Impact Assessments, and Criticality Assessments. Perform Quality Risk Assessments. Generate DQ/IQ/OQ/PQ protocols under limited supervision. Execute IQ/OQ/PQ per protocols and write qualification reports. Review qualification documents to ensure compliance to SOPs. Assure and apply GMP throughout operations. Meet schedules, timelines, deadlines.
Skills and Qualification: A positive attitude and willingness to learn new concepts and new work knowledge required. Strong coordination and organization skill. Ability to write clearly and effectively. Strong verbal communication skills. Previous hands-on experience in equipment qualification is a plus. Working knowledge of Microsoft office as well as software used in analytical and bioanalytical instruments. Good organizational skills and detail-oriented. Capable of completing assigned responsibilities within deadlines and keeping manager informed of status. Familiarity with GMP requirements and compliance, particularly good documentation practices.
Education B.A. or B.S. degree (preferably in relevant scientific discipline) or an equivalent combination of education and experience.