Job Description

Job Overview

We are seeking a detail-oriented and knowledgeable Quality Assurance Specialist to join our team. This role is essential in ensuring that our products meet the highest standards of quality and compliance with industry regulations. The ideal candidate will have a strong background in quality management systems and experience in manufacturing environments, particularly within regulated industries. You will be responsible for implementing and maintaining quality assurance processes, conducting audits, and ensuring compliance with FDA regulations, ISO standards, and other relevant guidelines.

Preferred Qualification

Supply Chain; Incoming sampling and inspection; Quality audit of warehouse floor operations; Proficient in Smartsheet, Generative AI, Power BI, SAP; Initiating and approving Quality deviations (nonconformances)

Duties

- 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 Amgen Values/Leadership Practices.

Job Types: Full-time, Contract

Pay: $40.00 - $42.00 per hour

Work Location: In person