Overview
Specialist , QA Data Integrity Jobs in Baltimore, Maryland, USA at Bora Pharmaceuticals
Position: Specialist I, QA Data Integrity
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Job Summary
The Data Integrity Specialist will be responsible for assisting the Camden facility in determining systems impacted by data integrity requirements. The role requires a thorough understanding of data integrity and 21 CFR Part 11 requirements. The position involves working with cross-functional teams to identify computerized needs for new systems, upgrades, and decommissioning, ensuring proper equipment use and compliance. Strong technical knowledge of computerized laboratory and enterprise systems, GAMP processes, and risk management is essential.
Mechanical aptitude with manufacturing equipment in an aseptic GMP facility is also required.
Essential Functions
Provides technical expertise on GMP equipment supporting the Data Integrity Program.
Reviews and approves validation and technical documents, facilities, and maintenance documents to support Quality Systems.
Represents Quality in decision-making regarding CAPEX and validation projects.
Contributes to company objectives using broad expertise and skills.
Acts as a change agent for continuous improvement.
Interacts with managers and peers to ensure alignment on quality decisions.
Supports regulatory and internal inspections as needed.
Leads cross-functional teams in process mapping and understanding exercises.
Works independently, managing time effectively.
Reviews and approves documents meticulously on behalf of Quality Systems.
Supports GMP departments across the site and provides onsite support for manufacturing.
Minimum Education
, Experience, Skills
Bachelor’s degree in science or engineering from an accredited institution.
At least 7 years of relevant cGxP experience in biopharmaceutical or life sciences manufacturing or development.
Experience investigating deviations, root cause analysis, and corrective actions.
Knowledge of pharmaceutical equipment such as bioreactors, centrifuges, CIP skids, autoclaves, HVAC, and WFI systems is advantageous.
Proven ability to exercise independent judgment, technical proficiency, and collaborate in a cGMP environment.
Excellent communication, organizational, and interpersonal skills.
Ability to manage multiple activities and prioritize effectively.
Demonstrates initiative and the ability to make sound independent decisions.
Physical/Mental Demands and
Work Environment
The physical and mental demands are typical for this role, and accommodations may be provided for individuals with disabilities.
Compensation Range
$91,719.00 – $
Additional Details
Seniority level:
Mid-Senior level
Employment type:
Full-time
Job function:
Quality Assurance
Industry: Pharmaceutical Manufacturing
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Title: Specialist , QA Data Integrity
Company: Bora Pharmaceuticals
Location: Baltimore, Maryland, USA
Category: Quality Assurance – QA/QC (Quality Engineering, QA Specialist / Manager, Quality Control / Manager)
