Specialist QA 34063

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:
Bachelors degree and 5 years of directly related experience