The Quality Assurance Specialist performs a range of responsibilities supporting Quality Assurance program under minimal supervision. This role ensures compliance with cGMP regulations, company policies, and quality standards by reviewing and approving manufacturing documentation, leading investigations and audits, and supporting cross-functional initiatives related to product quality, process validation, and release activities.
Key Responsibilities
- Review and approve product Master Production Records (MPs) and related documentation.
- Approve process validation protocols and reports to ensure manufacturing process compliance and consistency.
- Approve Environmental Characterization reports and planned incidents.
- Review and approve Work Orders, EMS/BMS alarms, and associated corrective actions.
- Approve Non-Conformance (NC) investigations, CAPA records, and change controls.
- Provide lot disposition and authorize product lots for shipment.
- Serve as a QA representative on cross-functional teams, including New Product Introduction (NPI) and incident triage teams.
- Lead or participate in site audits, ensuring readiness for internal and external inspections.
- Act as designee for the QA Manager during local Change Control Review Board (CCRB) meetings.
- Own and maintain site quality program procedures, ensuring continuous compliance and improvement.
- Review and approve risk assessments related to manufacturing, facilities, and environmental systems.
- Provide QA support for automation initiatives, environmental programs, and facility systems.
- Support the release of sanitary utility systems.
- Coordinate with manufacturing, quality control, validation, and process development teams to ensure quality alignment.
- Participate in and lead investigations to identify root causes and implement effective corrective actions.
Skills
- Strong understanding of manufacturing, distribution, quality systems, validation, and process development.
- Proficient in evaluating compliance issues and leading investigations.
- Excellent organizational and project management skills with ability to manage multiple priorities.
- Effective communicator with strong written, verbal, facilitation, and presentation abilities.
- Skilled at influencing and leading cross-functional teams and initiatives.
- Proficient in data trending, evaluation, and interpretation to support decision-making.
- Advanced computer proficiency, including MS Office Suite (Word, Excel, PowerPoint) and database applications.
- Ability to work independently while collaborating effectively across all organizational levels.
- Experience interacting with regulatory agencies and ensuring audit readiness.
- Demonstrates Amgen’s Leadership Practices and Core Values.
Requirements
Education:
- Doctorate OR
- Master’s degree + 2 years of directly related experience OR
- Bachelor’s degree + 4 years of directly related experience OR
- Associate degree + 8 years of directly related experience OR
- High school diploma / GED + 10 years of directly related experience
Preferred Qualifications
- Experience in Supply Chain operations, including incoming sampling and inspection and warehouse quality audits.
- Proficiency with Smartsheet, Power BI, SAP, and Generative AI tools for quality data tracking and reporting.
- Experience initiating and approving Quality Deviations (Non-Conformances) and CAPA management.
- Demonstrated success coordinating quality improvement initiatives across manufacturing and logistics functions.
- Strong analytical mindset with ability to apply data-driven insights to enhance quality performance.
Benefits
- 3 year contract
- 3rd Shift
Top Skills
What We Do
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results.
Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields.
We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions.
BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
