CQV Validation Contractor - Pharma QA Lead

Intellectt Inc; Greenville (NC); On-site; USD 62,000 - 69,000; Full time

Benefits offered by this job

Health Insurance (not specified)

401(k) retirement option

Paid time off as per state laws

Job summary

Intellectt Inc seeks a Validation Contractor to support QA oversight of CQV activities at a regulated manufacturing site in Greenville, NC. You will review qualification documents, ensure cGMP compliance, and support validations across facilities, equipment, utilities, cleaning procedures, and manufacturing processes.

Collaborate with Quality, Engineering, Validation, Manufacturing, MSAT, and QC teams to maintain inspection readiness and address compliance.

Qualifications

• Minimum of 7 years of experience in pharmaceutical or medical device industries.
• At least 5 years of hands-on experience in Engineering, Validation, or CQV.
• Strong understanding of cGMP requirements and regulations (21 CFR 210/211, 600, 820).
• Knowledge of ISO 13485, ISO 9001, and ICH Q9/Q10.
• Experience reviewing and approving qualification and validation protocols and reports.
• Experience with deviations, CAPAs, change controls, and regulatory inspections readiness.
• Familiarity with electronic quality management systems (Documentum, Veeva Vault, TrackWise).
• Strong analytical, troubleshooting, documentation, and communication skills.

Responsibilities

• Review, author, and approve URS, commissioning plans, IQ/OQ/PQ protocols and reports.
• Provide risk-based QA oversight for equipment qualification, CSV, cleaning validation, and process validation.
• Review APQRs and support maintenance of site VMPs.
• Provide QA validation expertise for deviations, CAPAs, and change controls.
• Collaborate with MSAT, Engineering, Manufacturing, Validation, QC, and Maintenance during FAT, SAT, and startup activities.
• Support internal/external audits and regulatory inspections as a Validation SME.
• Review executed validation packages and monitor KPIs and trends for compliance risks.
• Ensure quality records, SOPs, and manufacturing documentation are accurate and retained per cGMP.
• Identify opportunities to improve CQV processes and implement quality initiatives.
• Provide guidance and training to junior QA Validation specialists and cross-functional teams.

Skills

CQV experience

cGMP knowledge

Regulatory compliance

Documentation review

Cross-functional collaboration

Audit support

Deviations & CAPAs

Validation protocols review

Education

Bachelor's degree in Engineering or related field

Tools

Documentum

Veeva Vault

TrackWise

Job description

Intellectt Inc seeks a Validation Contractor to support QA oversight of CQV activities at a regulated manufacturing site in Greenville, NC. You will review qualification documents, ensure cGMP compliance, and support validations across facilities, equipment, utilities, cleaning procedures, and manufacturing processes.

Collaborate with Quality, Engineering, Validation, Manufacturing, MSAT, and QC teams to maintain inspection readiness and address compliance.