Specialist QA

Weil Group, Inc; Juncos (PR); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

Weil Group, Inc. supports Amgen's Quality Assurance program from its site. The role drives QA oversight for manufacturing, validation and regulatory alignment, including leading investigations and site audits.

Applicants should have advanced degrees with substantial related experience and strong cross-functional leadership, communication and data analysis skills. The position emphasizes independent work and adherence to client values.

Formación

• Doctorate or masters with related experience as specified.
• Bachelor's degree with years of related experience as listed.
• Experience in QA, manufacturing, validation and distribution processes.
• Ability to interact with regulatory agencies and lead audits.

Responsabilidades

• Review and approve product MPs and process validation protocols/reports.
• Lead site investigations and CAPA records.
• Own site quality program procedures and QA oversight.
• Represent QA on NPI teams and coordinate cross-functional activity.
• Review risk assessments, change controls, EMS/BMS alarms and work orders.
• Support automation, facilities and environmental programs; market compliance.

Conocimientos

Project management

Organizational skills

Cross-functional leadership

Negotiation

Regulatory interaction

Data analysis

Communication

Independent work

Educación

Doctorate

Masters + 2 years of directly related experience

Bachelors + 4 years of directly related experience

Associates + 8 years of directly related experience

High school/GED + 10 years of directly related experience

Descripción del empleo

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.