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Key Responsibilities and Required Skills for Quality Control Data Reviewer

💰 $70,000 - $110,000

Quality ControlData ReviewPharmaceuticalBiotechnologyGxPLaboratory

🎯 Role Definition

The Quality Control (QC) Data Reviewer is responsible for the scientific and regulatory review of analytical and quality data to ensure product release decisions are compliant with company policies, cGMP/GLP regulations, and applicable health authority expectations. The QC Data Reviewer inspects raw and processed data from laboratory information management systems (LIMS/ELN), evaluates analytical method performance (HPLC/GC/LC/MS, wet chemistry, microbiology), documents data integrity assessments, prepares review summaries, and communicates findings with QC analysts, Quality Assurance (QA), and manufacturing stakeholders. This role requires strong technical knowledge of analytical testing workflows, excellent attention to detail, and the ability to drive CAPA and investigation activities where data or process deviations are identified.

📈 Career Progression

Typical Career Path

Entry Point From:

  • QC Analyst / Laboratory Analyst (wet chemistry, chromatography, microbiology)
  • Data Analyst with laboratory or manufacturing experience
  • Quality Assurance Associate with hands-on lab exposure

Advancement To:

  • Senior QC Data Reviewer / Lead QC Reviewer
  • Quality Assurance Specialist / QA Review Lead
  • QC Data Integrity SME or LIMS Specialist
  • Manager, Quality Control or QA Manager

Lateral Moves:

  • LIMS/ELN Administrator
  • Analytical Development Scientist
  • Regulatory Affairs Associate

Core Responsibilities

Primary Functions

  • Conduct thorough scientific review of raw and processed analytical data (chromatograms, spectra, instrument logs, electronic notebooks, and printouts) to confirm accuracy, completeness, and suitability for batch release decisions in accordance with cGMP, GLP, and internal procedures.
  • Review LIMS/ELN entries, instrument files, and audit trails to verify data integrity (ALCOA+ principles): ascertain that data are attributable, legible, contemporaneous, original and accurate and identify any signs of data manipulation or missing audit trail entries.
  • Evaluate analytical method performance metrics (system suitability, calibration, accuracy, precision, %RSD, correlation coefficients) and confirm that acceptance criteria were met before recommending product disposition or further testing.
  • Perform trending and statistical analysis of QC data (e.g., stability, method performance, out-of-specification (OOS) trends) using Excel, statistical tools, or internal dashboards to detect shifts, drifts, and patterns requiring corrective action.
  • Prepare and document data review summaries and justification memos that clearly describe findings, deviations, corrective actions, and final recommendations for QA or Manufacturing release.
  • Lead or support OOS/OOT investigations by reviewing raw data, method execution records, instrument maintenance logs, and analyst worksheets; identify root causes and recommend CAPA or re-test plans.
  • Verify completeness and compliance of test records, SOP adherence, reagent and standard traceability, calibration certificates, and environmental monitoring records before approving test results.
  • Coordinate with QC analysts and supervisors to clarify results, request confirmatory testing or re-analysis, and close open items in a timely manner to support product release schedules.
  • Review microbiological data (bioburden, sterility, environmental monitoring) and perform specialized assessments for contamination events, sampling methods, and corrective actions.
  • Ensure all reviews are documented in accordance with company policies and that review sign-offs are performed within established turnaround times and review timelines.
  • Provide technical input on the development, validation, and lifecycle maintenance of analytical methods and review method validation/qualification reports to ensure data reviewability.
  • Conduct periodic data integrity and compliance audits of QC records and LIMS configurations, and work with QA/LIMS teams to remediate identified gaps.
  • Maintain up-to-date knowledge of regulatory requirements (FDA, EMA, ICH, USP) and industry best practices relevant to QC data review, and incorporate changes into routine review activities.
  • Train and mentor junior reviewers and QC analysts on data review procedures, data integrity expectations, and best practices for documentation and recordkeeping.
  • Participate in CAPA investigations and root cause analysis workshops, contribute data-driven evidence, and help implement corrective actions to prevent recurrence of data quality issues.
  • Review instrument qualification and calibration documentation to ensure instruments used for release testing were in a qualified state at time of testing.
  • Collaborate with QA, Manufacturing, and Regulatory teams to support product disposition meetings and regulatory submissions that require QC data summaries and review attestations.
  • Escalate significant nonconformances or suspected data integrity issues in accordance with internal reporting procedures and support regulatory inspections and internal audits as a subject matter expert.
  • Maintain effective communication with cross-functional stakeholders (analytical development, manufacturing, QA, QC management) to ensure alignment on release decisions, investigations, and process improvements.
  • Contribute to the development and maintenance of SOPs, work instructions, templates, and checklists for QC data review to improve consistency, reproducibility, and review quality.
  • Monitor workload and review metrics, help prioritize reviews to support business timelines, and participate in continuous improvement initiatives to increase review efficiency.
  • Support electronic record migration, validation, and system upgrades by testing review workflows, documenting functional specifications, and providing acceptance criteria from the reviewer perspective.
  • Assess and document the impact of deviations, investigations, and out-of-specification results on product quality and support the generation of accurate technical reports for regulatory correspondence.
  • Ensure confidentiality and secure handling of all laboratory and quality records in line with company policy and regulatory requirements.

Secondary Functions

  • Support ad-hoc data requests and exploratory data analysis.
  • Contribute to the organization's data strategy and roadmap.
  • Collaborate with business units to translate data needs into engineering requirements.
  • Participate in sprint planning and agile ceremonies within the data engineering team.

Required Skills & Competencies

Hard Skills (Technical)

  • Deep knowledge of cGMP/GLP regulations, ICH guidelines, and FDA/EMA expectations for laboratory data review and product release.
  • Hands-on experience with LIMS/ELN systems (e.g., Thermo Fisher SampleManager, LabWare, STARLIMS, Benchling) for review and data retrieval.
  • Proficiency in reviewing chromatography and spectroscopy data formats (HPLC, GC, LC-MS, UV, IR) and ability to interpret chromatograms and instrument reports.
  • Strong Excel expertise (pivot tables, VLOOKUP/XLOOKUP, data cleaning, statistical calculations) and basic familiarity with statistical software or scripting (Minitab, R, Python, SAS) for trend analysis.
  • Experience with laboratory instrumentation qualification/validation documentation and the ability to assess instrument status during data review.
  • Practical understanding of data integrity principles (ALCOA+) and audit trail analysis for electronic records.
  • Ability to author clear, regulatory-quality review summaries, deviation reports, and CAPA documentation.
  • Familiarity with microbiology testing and interpretation of sterility/bioburden/environmental monitoring results (preferred for sterile product environments).
  • Experience with batch release workflows and manufacturing change control processes.
  • Knowledge of root cause analysis methodologies (5 Whys, Fishbone/Ishikawa, FMEA).
  • Experience participating in regulatory inspections and supporting responses to audit findings.
  • Understanding of chromatography data system (CDS) software (e.g., Empower, Chromeleon) is a plus.

Soft Skills

  • Exceptional attention to detail and a methodical, analytical mindset for evaluating complex datasets.
  • Strong written and verbal communication skills to prepare review reports and interact with cross-functional stakeholders.
  • Critical thinking and problem-solving aptitude, with the ability to synthesize technical information and make risk-based recommendations.
  • Time management and prioritization skills to handle high-volume review queues and support tight release timelines.
  • Team orientation with demonstrated ability to mentor junior staff and collaborate across QA/QC/Manufacturing.
  • Ethical judgment and integrity, with a commitment to compliance and responsible data stewardship.
  • Adaptability and continuous learning mindset to stay current with evolving regulations, technologies, and best practices.
  • Project and change management awareness to contribute to system upgrades and process improvement initiatives.

Education & Experience

Educational Background

Minimum Education:

  • Bachelor's degree in Chemistry, Biochemistry, Molecular Biology, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline.

Preferred Education:

  • MS or advanced degree in a relevant scientific field, or certification in quality systems, regulatory affairs, or data integrity.

Relevant Fields of Study:

  • Analytical Chemistry
  • Biochemistry
  • Pharmaceutical Sciences
  • Microbiology
  • Chemical Engineering

Experience Requirements

Typical Experience Range:

  • 3–7 years of hands-on QC laboratory experience with increasing responsibility in data review, investigations, or quality systems; or 1–3 years with an advanced degree.

Preferred:

  • 5+ years of combined QC and data review experience in a regulated environment (pharmaceuticals, biotech, medical devices) including demonstrated experience with LIMS/ELN, chromatography data systems, OOS investigations, and regulatory inspections.
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