QC Investigator: CAPA & Deviation Lead

Evolving Solution Services; Dallas (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Evolving Solution Services in Dallas, TX, is seeking a QC Investigator to lead investigations related to QC deviations, OOS findings, and CAPAs in an FDA-regulated setting. You will ensure timely closure of records, perform root-cause analyses, and drive continuous improvement across QC metrics.

The role interfaces with SMEs, QA, and operations, supports regulatory inspections, and uses QMS and data-tracking tools to maintain robust investigation records and summaries.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Life Sciences, or related field.
• 2–4 years of QC or technical writing/investigation experience in an FDA-regulated cGMP environment.
• Experience authoring technical deviations, OOS investigations, CAPAs, and effectiveness checks.
• Strong knowledge of cGMP regulations, FDA guidelines, root-cause methodologies, and lab documentation practices.
• Ability to manage multiple quality records and meet tight deadlines.

Responsibilities

• Lead end-to-end QC deviation investigations (OOS, OOT, and lab events).
• Ensure on-time opening and logging of quality records after event identification.
• Collaborate with SMEs, QA, and operations to perform root-cause analyses using RCA tools.
• Design, author, and implement CAPAs; monitor effectiveness checks.

Skills

Technical writing

Investigation skills

Cross-functional collaboration

Regulatory knowledge

Education

Bachelor's degree in Chemistry/Life Sciences

Tools

TrackWise

Veeva Vault

Master Control

LIMS

Excel

Job description

Evolving Solution Services in Dallas, TX, is seeking a QC Investigator to lead investigations related to QC deviations, OOS findings, and CAPAs in an FDA-regulated setting. You will ensure timely closure of records, perform root-cause analyses, and drive continuous improvement across QC metrics.

The role interfaces with SMEs, QA, and operations, supports regulatory inspections, and uses QMS and data-tracking tools to maintain robust investigation records and summaries.