<span>Specialist I, QA-Data Integrity</span>

$91,000 - $137,000/Yr

Bora Pharmaceuticals CDMO - Baltimore, MD

Full-time - Mid Level

Baltimore, MD

About the position

The Data Integrity Specialist at Bora Pharmaceuticals is responsible for ensuring compliance with data integrity requirements across the Baltimore facility. This role involves working with cross-functional teams to assess and enhance computerized systems, ensuring they meet regulatory standards, particularly 21 CFR Part 11. The specialist will provide technical quality reviews, support validation projects, and facilitate continuous improvement initiatives within the organization.

Responsibilities

• Assist in determining systems impacted by data integrity requirements.
• Work with cross-functional teams to identify computerized needs for new systems, upgrades, and decommissioning.
• Provide technical quality review and approval of validation and technical documents.
• Represent Quality in decision-making regarding CAPEX and validation projects.
• Serve as a change agent for continuous improvement within the scope of work.
• Support regulatory and internal inspection activities as needed.
• Coordinate and lead cross-functional teams in process mapping and system understanding exercises.
• Conduct thorough reviews and approve documents on behalf of Quality Systems.

Requirements

• Bachelor's degree in science or engineering from an accredited university or college.
• A minimum of seven (7) or more years of relevant cGxP experience in a biopharmaceutical or life sciences development or manufacturing environment.
• Experience with investigations into deviations and determination of impact, root cause, and corrective actions.
• Knowledge of pharmaceutical equipment such as bioreactors, centrifuges, CIP skids, autoclaves, and HVAC systems.
• Demonstrated success in independent judgment and technical proficiency in a cGMP environment.
• Excellent written and verbal communication skills.
• Strong organizational and interpersonal skills.
• Ability to manage multiple activities while maintaining a high level of organization.

Nice-to-haves

• Experience with computer system validation and software development life cycle.
• Familiarity with GAMP processes and risk management.

Benefits

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance