Validation Specialist

4 days ago

Boston, Massachusetts, United States TruMinds Clinical Full time $80,000 - $120,000 per year

Validation Specialist -- ONSITE.

Responsibilities:

Quality Operations - Responsible for the processing and maintenance of SOPs for the business segment. Compiles quality data and trends for Quality Management and Product Reviews.

Quality and Regulatory Compliance - Provides support and management of regulatory inspections and tracking inspectional responses. Training coordinator function responsibilities.

Quality Systems - Maintains knowledge in both current and emerging GxP requirements and quality trends as they relate to Medical Device and Combination Products worldwide, and supports and executes changes to quality standards/policies to ensure conformance.

Organisation Effectiveness and Strategic Direction - Types routine memos and letters, composes correspondence, schedules meetings, sets up filing systems, gathers information, answers questions on department and company policies and procedures, prepares basic reports, compiles statistics, and sets up databases.

Assists with special projects, collecting and collating documents and materials as requested.

Assists the functional area in compiling and generating reports, timelines, correspondence and presentations.

Qualifications

Bachelor's degree required in a scientific discipline or equivalent experience.

7+ years of combined experience in Manufacturing, QA, R&D in the pharmaceutical, biologics, device or chemical industry

Demonstrated knowledge of and experience with quality systems, corrective action and preventive action systems, and other key tools for managing global quality performance in a regulated industry.

Ability to work in a multinational, multicultural and highly matrixed environment.

Strong communication Skills, both oral and written

Proficient in computer skills and hands-on experience with database management, spreadsheets, project management, presentations, word processing, flowcharting and/or any other similar type of software.

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