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.
Skills Required
- Experience performing batch record (EBR) review, approval, and reconciliation
- Oversight of manufacturing operations
- Manage events and decision making
- Strong organizational skills with ability to follow assignments through to completion
- Initiate and lead cross functional teams
- Skills in leading, influencing, and negotiating
- Strong knowledge in area of expertise (QA/validation/process development)
- Collaborate and coordinate with higher level outside resources
- Experience with manufacturing and distribution, QA, QAL, validation and process development
- Ability to interact with regulatory agencies
- Word processing, presentation, database and spreadsheet application skills
- Strong written and oral communication, facilitation and presentation skills
- Ability to work independently and effectively interact with various levels
- Advanced data trending and evaluation
- Ability to evaluate compliance issues
- Education: Doctorate OR Master's + 2 years scientific experience OR Bachelor's + 4 years scientific experience
What We Do
Inteldot offers custom turn-key systems, systems integration, MES eBR configuration and integration solutions, business intelligence and analytics and technical staffing. We have been providing the Pharmaceutical, Manufacturing and Medical Device industries with services for a variety of applications since 2004
