Analyst III, QA Batch Release

Emergent BioSolutions - Baltimore, MD

Full-time - Entry Level

Baltimore, MD

Chemical Manufacturing

About the position

The QA Analyst III is a pivotal role within Emergent BioSolutions, responsible for managing records pertinent to the review and release of Batch Records in compliance with current Good Manufacturing Practices (cGMP) at the Baltimore Camden Site. This position is integral to ensuring that the company's operations meet the highest standards of quality and compliance, thereby protecting and enhancing lives through the development of critical health products. The QA Analyst will engage with various departments to provide essential guidance aimed at maintaining and improving cGMP compliance across the organization. In this role, the QA Analyst will critically review a variety of GMP documents, including executed batch records, analytical testing data, microbial and environmental monitoring data, and equipment data. The analyst will also perform SAP transactions, address client comments promptly, and conduct Product Disposition meetings, ensuring that all follow-up information is accurately documented. Additionally, the QA Analyst will be responsible for analyzing and publishing department metrics, entering post-release batch data, reviewing documentation for shipment authorization, and initiating non-conformance investigations. Strong organizational skills are essential, as the analyst will need to prioritize and manage multiple tasks effectively in a dynamic environment. The QA Analyst III will also play a key role in quality operations support by compiling and reporting performance metrics related to Batch Review and Release activities. Continuous improvement is a core focus of this position, with the analyst expected to identify opportunities for enhancement within their scope of work and participate in operational excellence initiatives. Furthermore, the QA Analyst will provide logistical support and technical expertise during regulatory and internal inspections of Emergent's quality systems, ensuring that the company adheres to all regulatory requirements and standards.

Responsibilities

• Critically review GMP documents such as executed batch records, analytical testing data, and microbial monitoring data.
• Perform SAP transactions related to batch release processes.
• Address and respond to client comments in a timely manner.
• Conduct Product Disposition meetings and follow up on information from these meetings.
• Analyze and publish department metrics related to batch review and release activities.
• Post release batch data entry and review documentation for shipment authorization.
• Review and fill ancillary forms and scan released batch records for filing.
• Initiate non-conformance investigations as necessary.
• Compile and report performance metrics for Batch Review and Release activities.
• Identify opportunities for improvement within the scope of work and participate in operational excellence activities.
• Provide logistical support and technical knowledge during regulatory and internal inspections.

Requirements

• BS degree in Chemistry/Biology or related discipline with 1-3 years of Quality Control or Quality Assurance experience, or a MS degree in Chemistry/Biology with at least 1 year of Quality Assurance experience.
• 1 year of experience in an FDA regulated industry is preferred.
• Strong attention to detail and ability to manage multiple priorities in a dynamic environment.
• Excellent written and verbal communication skills.
• Ability to exercise judgment to determine appropriate corrective actions and compliance-related decisions with moderate supervision.
• Working knowledge of cGMP and ability to make sound decisions regarding compliance-related issues.
• Ability to use computer programs and work effectively in a team environment.

Nice-to-haves

• Experience with regulatory inspections and quality systems management.
• Familiarity with SAP or similar enterprise resource planning software.

Benefits

• Health insurance coverage
• 401k retirement savings plan
• Paid holidays and vacation time
• Professional development opportunities
• Diversity and inclusion programs