Job description

Job Title – US_Validation Specialist_Engineer I

Location – South San Francisco CA 94080

Duration- 6 Months

Job Description

Important: *** has mandated COVID-19vaccination for their workforce, effective October 1st, 2021. All external personnel providing services to *** are required to comply with this requirement.

Site/Commercial Quality Control at *** is 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
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.

Thanks and Regards
Sai Sree

Job Type: Contract

Pay: $80.00 per hour

Schedule:

• 8 hour shift

Education:

• Bachelor's (Required)

Experience:

• Quality Risk Assessments: 6 years (Required)
• CGMP: 6 years (Required)

Work Location: One location

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