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Senior Consultant, Quality Compliance & Data Integrity
Career Insights for Validation Specialist
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Based on North Carolina data
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What they do
A Validation Specialist tests and documents the validity and accuracy of manufacturing systems and equipment. Tests processes and manages process validations. Provides technical support and implements operating procedures. May create documentation to show that a manufacturing or production process has consistent results and meets quality standards.
$88,298 / year median in North Carolina
+6% projected growth
Job Description
Senior Consultant, Quality Compliance & Data Integrity#26-09512
$50 per hour
Greenville, NC
Onsite Job Description
At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a Senior Consultant, Quality Compliance & Data Integrity.
Position Type:
Contract
On-Site Required:
10+ years of pharmaceutical/GMP experience, preferably in sterile manufacturing.
Strong expertise in Data Integrity and Quality Compliance.
Proven experience with retrospective data reviews and FDA remediation.
Strong understanding of
ALCOA+, 21 CFR
Part 11, GMP documentation, deviations, investigations, and CAPA.
Previous experience supporting an FDA inspection, Form 483 response, or remediation program is highly desirable.
Experience reviewing equipment and process qualification documentation, including IQ/OQ/PQ and associated validation records, deviations, change controls, and requalification activities.
Demonstrate strong analytical skills, attention to detail, regulatory judgment, and the ability to work independently within a demanding remediation environment.
Responsibilities:
Conduct comprehensive retrospective review of GMP documentation and historical data.
Review and assess qualification and validation documentation for manufacturing equipment, systems, utilities, processes, and associated validation/qualification records. Including URS, IQ, OQ, PQ, commissioning documentation, protocols, reports, deviations, and associated change controls, to determine whether equipment and processes were appropriately qualified and remain in a validated state.
Assess records and data against
ALCOA+, FDA
cGMP, and Data Integrity requirements.
Identify potential data integrity, GMP, and compliance gaps and assess their potential impact on product quality and sterility assurance.
Review relevant batch records, deviations, CAPAs, environmental monitoring, microbiology, validation/qualification, and computerized system records.
Support investigations, root cause analysis, impact assessments, and remediation activities related to the FDA 483 observations.
Clearly document findings, rationale, and recommendations in an inspection-ready format.
Evaluate process equipment and manufacturing systems used in sterile product manufacturing, including equipment qualification records, operating parameters, alarms, controls, maintenance/calibration records, and associated procedures, and assess their potential impact on product quality, data integrity, and sterility assurance.
Get in
Touch:
We want to hear from you! If you think you'd be a good match, submit your resume and reach out to Komal at 862-390-7418 to learn more.