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.
Administrative Shift
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:
- Change Control
- Documentation Review
- Validation
- PPQ
- Project management skills.
- 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
Functions:
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes.
- Request Quality on incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Lead site audits.
- Own site quality program procedures.
- Designee for QA manager on local CCRB.
- Review Risk Assessments.
- Support Automation activities.
- Support facilities and environmental programs.
- Review and approve Work Orders.
- Review and approve EMS/BMS alarms.
- Approve NC investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment
Education
- Masters + 2 years of directly related experience OR Bachelors + 4 years of directly related experience
Skills Required
- Experience with change control
- Experience with documentation review
- Experience with validation and PPQ
- Project management skills
- Strong organizational skills and ability to complete assignments
- Ability to initiate and lead cross-functional teams
- Skills in leading, influencing, and negotiating
- Strong knowledge in the relevant area of expertise
- Ability to collaborate and coordinate with external resources
- Experience with manufacturing and distribution processes, 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 interact effectively with multiple organizational levels
- Advanced data trending and evaluation skills
- Ability to evaluate compliance issues
- Master's degree plus 2 years of directly related experience, or bachelor's degree plus 4 years of directly related 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
