3098 Validation Specialist III

Duties:
Site/Commercial Quality Control is seeking an associate to plan, coordinate, execute and document qualification of QC equipment and associated software.
The person is also responsible for equipment maintenance and management of 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:
Plan, coordinate, execute and document qualification of QC equipment and associated software compliance with GMP requirements.
Generate 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.
May present equipment qualification during internal and external audits and regulatory inspections. 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.