Quality Control Data Integrity Specialist

Job Description

Company Description

Stira Pharmaceuticals is a sterile injectable CDMO based in Fairfield, NJ. We specialize in pharmaceutical product development and manufacturing of small molecules and peptides. Our services span Analytical R&D, Formulation Development, Regulatory Support, and more. Backed by a team of highly skilled scientists, Stira brings deep technical expertise and a proven track record in developing complex and challenging products.

Role Description

Stira Pharmaceuticals is seeking a meticulous and experienced Quality Control Data Integrity Specialist to join our Quality Control team in Fairfield, NJ. This full-time, on-site role is responsible for safeguarding the integrity, accuracy, and compliance of data generated from QC testing. The successful candidate will play a critical role in ensuring that all QC documentation meets Good Manufacturing Practice (GMP) requirements and regulatory expectations, with a particular focus on cross-validation using orthogonal analytical techniques.

Key Responsibilities

• Review raw QC data for completeness, accuracy, and compliance with GMP and regulatory standards.
• Verify that QC test methods and protocols are consistently followed and align with approved specifications.
• Ensure data integrity for results generated from advanced analytical platforms, including HPLC, GC, FTIR, UV-Vis, LC/HRMS, ICP-MS, and other orthogonal techniques.
• Critically evaluate data by confirming results through orthogonal testing approaches, ensuring robustness and reliability of conclusions.
• Identify, document, and resolve discrepancies, deviations, or errors in QC records; collaborate with laboratory staff to implement corrective and preventive actions.
• Ensure accuracy and completeness of QC documentation, including laboratory notebooks, instrument logs, and certificates of analysis.
• Partner with Quality Assurance and Regulatory Affairs to uphold data integrity and compliance across submissions and inspections.
• Review and approve QC documentation to support material and product release.
• Support internal audits and regulatory inspections by maintaining ready access to accurate QC records.
• Provide training and guidance to QC staff on data integrity principles, documentation practices, orthogonal method utilization, and regulatory compliance.
• Stay current with evolving regulations, industry guidance, and best practices in QC data integrity and orthogonal testing.

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Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
• Minimum 3 years of QC data review or data integrity experience within the pharmaceutical or biotechnology industry.
• Strong knowledge of GMP, GLP, and applicable global regulatory requirements.
• Hands-on experience with QC analytical techniques such as HPLC, GC, FTIR, UV-Vis, LC/HRMS, ICP-MS, and other orthogonal technologies.
• Demonstrated ability to apply orthogonal techniques for data confirmation and cross-validation.
• Exceptional attention to detail with a strong focus on data accuracy and integrity.
• Strong organizational and time management skills; able to manage multiple priorities effectively.
• Excellent communication and interpersonal skills for cross-functional collaboration.
• Proficiency with Laboratory Information Management Systems (LIMS) and electronic data systems preferred.
• Familiarity with regulatory submissions (ANDA, IND, NDA) is a plus.