Quality Assurance Specialist II

Quality Assurance Specialist II

Our Frederick Manufacturing Center (FMC) creates life-changing medicines for people around the world and has been recognized by our local community as being a Top 50' Business in Frederick and awarded Frederick County's 'Best Place to Work'. This distinctive biologic manufacturing facility, with over 800 employees, makes a direct contribution to treating people with cancer, respiratory and autoimmune conditions across the globe. We work hard to deliver life-changing medicines to patients, and we take time to have fun and celebrate our accomplishments. From catered site festivities to competitive events, community outreach activities, environmental and wellness showcases and team-building functions, we take time to recognize our achievements and celebrate our diversity. We are dedicated to creating a culture of inclusion and collaboration and are committed to continuous learning by offering ongoing skill building and training for our staff.

Fueled by our aspiration to deliver accelerated growth for our company and to make people's lives better, there's never been a more exciting time to join the team and shape the future of AstraZeneca Operations.

Join us at AstraZeneca as a Quality Assurance Specialist within the Quality Systems group at Frederick Manufacturing Center. This role is designed to assist in all areas of quality systems, guided by the quality leads on the team. If you're ready to pioneer a new 'Quality way', this is the opportunity for you!

Position Summary

The Quality Assurance Specialist II provides Quality Assurance oversight for manufacturing and operational activities within a biopharmaceutical or pharmaceutical environment. The role is responsible for batch record review and release support, area release activities, review of electronic systems and manufacturing records, assessment of quality events, and execution of routine compliance activities.

The position works closely with Manufacturing, Quality Control, Quality Systems, Validation, Engineering, and other cross-functional teams to ensure that activities are performed in accordance with approved procedures, applicable regulations, and company quality standards. The role also contributes to continuous improvement initiatives and may support additional quality projects as assigned.

Shift: Nights, 6pm-6:30am (2-2-3 Manufacturing schedule)

Core Responsibilities

• Batch Review and Release: Perform batch review and release activities for paper-based batch records and electronic batch records (EBRs), ensuring documentation is complete, accurate, compliant with approved procedures, and assessed for potential product-quality impact.
• Area Release Activities: Perform or support area release activities, including product changeover, return-to-service assessments, and execution of the Quality Assurance hold process.
• Area Audits: Conduct area audits on a quarterly basis and document findings in accordance with applicable procedures.
• Lot Genealogy Reports: Prepare and review lot genealogy reports to support product traceability and compliance.
• Quality Systems Support: Provide backup support to the Quality Systems function, as needed.
• Deviation Assessment: Assess quality events to determine whether deviation initiation is required in accordance with the applicable DAI process.
• Floor Observations: Review, document, and close floor observations within established procedures and timelines.
• Autoclave Review: Review autoclave run cycles to verify compliance with approved procedures and assess potential impact on product quality.
• Electronic Logbook Review: Review electronic manufacturing records, including PAS-X and DeltaV electronic logbooks.
• PCS/BMS Alarm Review: Review PCS/BMS alarms and evaluate relevant information for potential impact on product quality, equipment performance, manufacturing operations, or regulatory compliance.
• Quality and Manufacturing Systems: Use and support activities associated with applicable site systems and platforms, including GQCLIMS View/Labeler, LAP MODA View, and SAP Labeler, in accordance with assigned access privileges and established procedures.
• Continuous Improvement: Participate in continuous improvement projects, including Lean initiatives, to improve quality processes, compliance, operational efficiency, and right-first-time performance.
• Additional Responsibilities: Support other quality-related projects and responsibilities as assigned based on business and site needs.

Required Education

A bachelor's degree in biology, engineering, or a related scientific or technical field is required.

Required Experience

• Minimum of three years of experience in a biopharmaceutical or pharmaceutical environment.
• Minimum of one year of experience in Quality Assurance, Quality Control, Validation, or a related quality function.
• Experience reviewing paper-based and electronic manufacturing documentation in a regulated environment.
• Experience working with quality systems, manufacturing records, deviations, observations, and compliance processes.
• Familiarity with electronic manufacturing and quality systems, such as PAS-X, DeltaV, PCS/BMS, GQCLIMS, LAP MODA, and SAP, is preferred or required according to site needs.

Knowledge, Skills, and Competencies

The Quality Assurance Specialist II should have a working knowledge of applicable GxP requirements, approved procedures, batch documentation practices, manufacturing processes, and quality systems. The role requires strong attention to detail and the ability to identify documentation discrepancies, assess potential quality risks, and escalate issues appropriately.

The successful candidate should demonstrate sound quality judgment, effective problem-solving skills, and the ability to work independently while collaborating with cross-functional teams. Strong written and verbal communication skills, effective time management, and the ability to manage multiple priorities are also required.

The role requires the ability to review manufacturing and electronic records, interpret process and equipment information, support deviation assessments, and contribute constructively to Lean and other continuous improvement initiatives.