QA Analyst III, Batch Release

Bora Pharmaceuticals CDMO - Baltimore, MD

Full-time - Mid Level

Baltimore, MD

About the position

The QA Analyst III at Bora Pharmaceuticals is responsible for managing records related to the review and release of Batch Records in a cGMP environment. This role involves critical review of GMP documents, interaction with various departments to ensure compliance, and participation in continuous improvement initiatives. The QA Analyst will also support regulatory inspections and contribute to quality operations by compiling performance metrics and addressing client comments.

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 outcomes.
• Analyze and publish department metrics related to batch review and release activities.
• Post release batch data entry and review of documentation for shipment authorization.
• Initiate non-conformance investigations and manage related documentation.
• Compile and report performance metrics for quality operations support.
• Identify opportunities for continuous improvement within the scope of work.
• Provide logistical support 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 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 for compliance-related issues with moderate supervision.
• Working knowledge of cGMP and quality systems.

Nice-to-haves

• Experience with SAP software.
• Familiarity with regulatory inspection processes.
• Experience in a team-oriented environment.

Benefits

• Health insurance
• Dental insurance
• 401(k)