Specialist QA 35471
Jornada completa
Inteldot
Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Shift (12 hour shift 5pm-5:30 am: Night shift Rotating coverage (including weekends and holidays)
Job Description:
Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities .
Requirements & Qualifications:
- Experience performing batch record (EBR) review, approval, and reconciliation
- Oversight manufacturing operations
- Manage events and decision making
- Strong organizational skills, including ability to follow assignments through to completion.
- Initiate and lead cross functional teams.
- Enhanced skills in leading, influencing and negotiating.
- Strong knowledge in area of expertise.
- Collaborate and coordinate with higher level outside resources.
- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
- Demonstrate ability to interact with regulatory agencies.
- Strong word processing, presentation, database and spreadsheet application skills.
- Strong communication (both written and oral), facilitation and presentation skills.
- Strong skill in working independently and to effectively interact with various levels.
- Advanced data trending and evaluation.
- Ability to evaluate compliance issues
Education
- Doctorate OR Master's + 2 years of Scientific experience OR Bachelors + 4 years of Scientific experience.
Vacante publicada el 29 días atrás
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