Quality Assurance Specialist (Biotech)
The Voluntary Protection Programs Participants' Association, Inc, Rochester, MN, United States
Overview
QA experience in a regulated laboratory environment with data integrity focus.
Qualifications
Strong knowledge of ALCOA+, FDA 21 CFR Part 11, ICH Q2(R1), and MHRA/WHO data integrity guidance
Strong expertise in data integrity, assay validation, method transfer, or lab QA
Familiarity with FDA BMV Guidance 2018 or EMA equivalent
Prefer GCLP/GLP experience in biotech or CRO/Contract Service Organization
Experience
Biotech: 3 years (Required)
Job Details
Job Type: Full-time
Pay: $75,000.00 - $110,000.00 per year
Work Location: In person
Benefits
Relocation assistance
#J-18808-Ljbffr
QA experience in a regulated laboratory environment with data integrity focus.
Qualifications
Strong knowledge of ALCOA+, FDA 21 CFR Part 11, ICH Q2(R1), and MHRA/WHO data integrity guidance
Strong expertise in data integrity, assay validation, method transfer, or lab QA
Familiarity with FDA BMV Guidance 2018 or EMA equivalent
Prefer GCLP/GLP experience in biotech or CRO/Contract Service Organization
Experience
Biotech: 3 years (Required)
Job Details
Job Type: Full-time
Pay: $75,000.00 - $110,000.00 per year
Work Location: In person
Benefits
Relocation assistance
#J-18808-Ljbffr