Specialist QA

Weil Group, Inc; Juncos (PR); On-site; USD 80,000 - 140,000; Full time

Job summary

Amgen seeks a QA professional to support its Quality Assurance program under minimal supervision. The role covers reviewing MPs, approving validation protocols, site audits, and leading QA-related investigations.

The ideal candidate will have strong cross-functional leadership, regulatory interaction experience, and the ability to manage projects from inception to completion. The position emphasizes independent work and adherence to QA standards.

Qualifications

• Advanced degree or equivalent experience in a related field.
• Experience with QA, QAL, validation and process development.
• Ability to lead cross-functional teams and manage projects.
• Strong interaction with regulatory agencies.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Lead site audits and investigations.
• Own site quality program procedures and related controls.
• Provide lot disposition and authorize lots for shipment.
• Review and approve change controls and EMS/BMS alarms.
• Support automation and facilities/environmental programs.
• Review risk assessments and CAPA records.
• Designee for QA manager on local CCRB.
• Represent QA on NPI team.

Skills

Project management

Cross-functional leadership

Regulatory interaction

QA knowledge

Validation

Process development

Data trending

Communication

Independent work

Negotiation

Education

Doctorate

Master's + 2 years related exp

Bachelor's + 4 years related exp

Associate + 8 years related exp

High school/GED + 10 years related exp

Job description

SUMMARY

Perform one or more of the following duties and responsibilities in support of Amgen's Quality Assurance program under minimal supervision.

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

• Doctorate OR
• Masters + 2 years of directly related experience OR
• Bachelors + 4 years of directly related experience OR
• Associates + 8 years of directly related experience OR
• High school/GED + 10 years of directly related experience.

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 Client Values/Leadership Practices.

*Weil Group is proud to be an Equal Employment Opportunity Employer.*