Inteldot has over 14 years in the life sciences industry with allocations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.
Job Description:
Perform one or more of the following duties and responsibilities in support of the Quality Assurance program under minimal supervision.
Non- standard Shift:
Monday – Friday 5:00 PM-5:30 AM
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.
Requirements and Responsibilities:
- Experience in reliability engineering, maintenance strategy, and process improvement.
- Working knowledge of pharmaceutical/biotech processes and ability to interpret and apply GLPs and GMPs.
- Familiarity with validation processes and documentation in a highly regulated environment.
- Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare parts' definition/accuracy/updates), reliability and change control assessments and requirements.
- Responsible for enhancing system reliability focusing on equipment availability, downtime reduction, and maintenance optimization.
- Develop equipment performance metrics (availability, downtime, etc.) with emphasis on identifying equipment performance improvement opportunities.
- Lead the implementation of equipment improvement projects.
- SME (Subject Matter Expert) for systems regarding design, maintenance, and point of contact during compliance operations.
- Support equipment troubleshooting within the functional area or in the scope of technical expertise.
- Support deviation process and define, implement, and own CAPAs associated with equipment within area of expertise.
Competencies/Skills:
- 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.
- Demonstrate the Amgen Values/Leadership Practice
Education/Licenses:
Bachelor's degree and 5 years of directly related experience