QA Specialist III

American Society for Quality; Juncos (PR); On-site; USD 140,000 - 190,000; Full time

Job summary

Weil Group seeks a senior QA leader to support Amgen's Quality Assurance program under minimal supervision. The role involves approval of MPs, process validation reports, incident triage, environmental reports, and release of sanitary utilities.

The candidate will lead cross-functional teams, review risk assessments, and own site quality procedures, with responsibilities including audits, CAPA records, change controls, and lot disposition for shipment.

Qualifications

• PhD or equivalent required for senior QA leadership.
• Advanced degree with directly related experience preferred.
• Proven ability to manage multiple QA projects simultaneously.
• Experience liaising with regulatory agencies and auditors.

Responsibilities

• 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.

Skills

Project management

Organizational skills

Cross-functional leadership

Negotiation

Regulatory interaction

Data analysis

Communication

Independence

Process understanding

Education

Doctorate

Masters + 2 years related experience

Bachelors + 4 years related experience

Associates + 8 years related experience

High school/GED + 10 years related experience

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.*