QC Lab Technical Reviewer – Data Integrity

KVK Tech, Inc.; Newtown Township (Delaware County); On-site; USD 52,000 - 76,000; Full time

Benefits offered by this job

401(k) with company match

Health, vision, and dental Insurance

Annual merit increases

Paid Time Off and Flexible Holidays

Job summary

KVK Tech, Inc. in Newtown, PA seeks a detail‑oriented Technical Reviewer to assure accuracy and completeness of laboratory data, calculations, and reports in line with cGMP.

The role reports to the Associate Director of QMS within Quality Assurance and supports raw material, finished product and stability testing. Recent graduates are encouraged to apply; training will be provided with progression to independent review after qualification.

Qualifications

• Bachelor's degree required in Chemistry, Pharmaceutical Sciences, or related field.
• 0–2 years in pharmaceutical or analytical laboratory; academic experience welcomed.
• Foundational analytical chemistry knowledge and solid laboratory documentation.
• Experience with analytical techniques such as HPLC, GC, UV-Vis, dissolution or titration preferred.
• Strong analytical, organizational, and documentation review skills.

Responsibilities

• Review laboratory raw data, worksheets, electronic records, and analytical reports for accuracy, completeness, traceability and compliance.
• Verify analytical calculations, sample and standard preparations, testing conditions, and reported results against original data.
• Evaluate chromatographic and other analytical data (HPLC, GC, dissolution) within training.
• Review electronic audit trails and supporting documentation to verify data changes and justification of reprocessing.
• Identify and escalate out‑of‑specification (OOS), out‑of‑trend (OOT), or other data integrity concerns.
• Document review findings, communicate discrepancies to laboratory personnel, and ensure corrections are addressed.
• Support review of method validation, transfer, stability documentation, and investigations.

Skills

Analytical mindset

Attention to detail

Documentation review

Education

Bachelor's degree in Chemistry or Pharmaceutical Sciences

Tools

HPLC

GC

UV-Vis

Dissolution

Titration

Job description

KVK Tech, Inc. in Newtown, PA seeks a detail‑oriented Technical Reviewer to assure accuracy and completeness of laboratory data, calculations, and reports in line with cGMP.

The role reports to the Associate Director of QMS within Quality Assurance and supports raw material, finished product and stability testing. Recent graduates are encouraged to apply; training will be provided with progression to independent review after qualification.