Senior QA Specialist, QC Instrument Validation (Onsite)

Planet Group; New York (NY); On-site; USD 62,000 - 76,000; Full time

Job summary

Planet Group in Southwest Boston seeks a Senior Specialist, Quality Assurance (QA) to provide hands-on quality oversight for QC instrument activities in a regulated GMP environment. You will review qualification documents, support data integrity, and ensure inspection readiness.

Candidates must have a bachelor’s degree in a science/engineering field and 3–8 years of CQV/qualification experience in biotech/biopharma or a related GMP setting, with US work authorization (USC/GC only; no

Qualifications

• Bachelor's degree in science or engineering and 3–8 years in CQV/qualification in GMP environments.
• Experience with deviation management and change control processes.
• Ability to review/approve validation/qualification documentation for data integrity.
• USC or GC work authorization; no sponsorship.

Responsibilities

• Review and approve QC equipment qualification/validation documentation (protocols, reports, periodic reviews)
• Review and approve QC method SOPs, forms, and data tables to support equipment readiness and data integrity
• Review QC logbooks and ensure documentation meets Good Documentation Practices
• Ensure QC personnel follow data integrity expectations and internal quality procedures
• Assess, classify, review, and approve deviations, change controls, CAPAs, work orders, and other quality system records
• Make quality decisions and provide guidance to maintain compliance with applicable regulations and internal requirements
• Execute work per approved procedures, SOPs, and work instructions
• Complete required training per assigned learning plan and requalification cadence
• Support audit/inspection readiness by ensuring documentation is complete, accurate, and readily retrievable

Skills

GxP knowledge

Deviation management

Change control

Documentation review

Attention to detail

Education

Bachelor's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field

Tools

Kneat

Job description

Planet Group in Southwest Boston seeks a Senior Specialist, Quality Assurance (QA) to provide hands-on quality oversight for QC instrument activities in a regulated GMP environment. You will review qualification documents, support data integrity, and ensure inspection readiness.

Candidates must have a bachelor’s degree in a science/engineering field and 3–8 years of CQV/qualification experience in biotech/biopharma or a related GMP setting, with US work authorization (USC/GC only; no