QC Data Reviewer I

Job Summary:

The Quality Control Data Reviewer I is responsible for the accurate and timely review of analytical data generated in the QC laboratory. This entry-level role ensures all documentation meets regulatory, internal, and client requirements in support of pharmaceutical product development and manufacturing. The Data Reviewer I will verify compliance with Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), and related company standard operating procedures (SOPs), state, FDA, local laws and international (e.g., EU, Chinese, Japanese) as applicable to maintain data integrity across analytical activities.

Duties/Responsibilities:

• Perform thorough review of analytical chemistry testing data for completeness, accuracy, and compliance with SOPs, test methods, and applicable regulatory standards.
  1. High-performance Liquid Chromatography (HPLC)
  2. Gas chromatography (GC)
  3. Dissolution
  4. Integrated Software Empower 3.
  5. UV-Vis Spectrophotometer
  6. Mastersizer 3000 for Particle Size Distribution (PSD)
  7. Karl Fischer (KF)
  8. pH
• Data Review of Analytical Chemistry Testing:
  1. Raw Material (RM) including API (active pharmaceutical ingredients) and excipients
  2. In Process (IP) Testing
  3. Clinical Verification
  4. Packaging Material
  5. Components
• Review the data to Comply with GLPs, cGMPs, and GDP (Good Documentation Practice).
• Confirm that calculations, units, and transcriptions are correct and traceable.
• Ensure chromatographic integrations and results are scientifically sound and compliant with established protocols.
• Verify that all test methods and procedures are properly followed and documented.
• Identify, document, and escalate any data discrepancies or deviations for investigation.
• Maintain a thorough understanding of current USP, EP, and ICH guidelines related to QC testing.
• Support audit readiness and participate in internal/external audits as needed.
• Collaborate closely with analysts, supervisors, and QA to resolve issues and ensure timely batch release.
• Maintain good documentation practices (GDP) and support data archival processes.
• Continuously improve and educate analytical chemists to improve analytical data reporting, adhering to GDP and cGMP to increase efficiency, compliance, and Quality.
• Review analytical data to ensure ALCOA+.
• Ensure compliance of testing with laboratory procedures, test methods, and protocols. Work with laboratory personnel to correct any errors and omissions in GMP documentation and promote a cGMP culture. Ability to pay attention to detail, focus, and multitask on review of analytical laboratory data.
• Adhere to the Safety and Health Program and associated plans.
• Review time of use logs on cGMP instrumentation and other analytical equipment.
• Completion of work within the assigned time frame, to perform or assist in general organizational tasks including open tasks and timelines and tracking of tasks.
• Knowledge of QA events/deviations/Investigations.
• Any other responsibilities are assigned by the manager or department head.

Required Skills/Abilities:

• Demonstrates excellent personal organizational skills
• Knowledgeable in Pharmaceutical industry regulations
• Health and Safety Awareness
• Must work as a team member in the QC Lab environment

Education and Experience:

• Bachelor's degree or higher, in Chemistry, Pharmacy, Sciences, or Quality (QA/QC), or equivalent work experience
• 0-3 years of relevant work experience in Quality Assurance/Data review of Chemistry QC in the pharmaceutical industry.
• Experience in all areas of Pharmaceutical, e.g., CMO, CDMO, Clinical and commercial products is preferred.
• Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project, Proofreading skills, etc.
• Knowledge of Quality Management Systems such as Master Control.
• Knowledge of current federal, local, and international regulations regarding the Testing, production, and release of drug substances and products.
• Basic understanding of analytical techniques (e.g., HPLC, GC) and laboratory data documentation requirements.
• Familiarity with cGMP, GLP, and regulatory compliance standards (FDA, EMA, ICH).
• Proficient in Microsoft Office (Word, Excel, Outlook); experience with electronic laboratory systems (e.g., Empower, LIMS, LabWare) is an advantage.
• Strong communication, organizational, and time management skills.
• Ability to manage multiple priorities and re-prioritize tasks as required.
• Strong attention to detail and ability to detect data inconsistencies.
• Excellent problem-solving skills.

Physical Requirements:
• Fluent in English
• Ability to travel between and within facilities to visit staff, operations, projects, etc.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).

All job requirements in the job description provided indicate the level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.