QA Specialist - Biopharma, On-Site Contract (18-24 mo)

Healing Strides Counseling; Signal Hill (CA); On-site; USD 28,000 - 40,000; Full time

Job summary

Sapta is seeking a QA Specialist for our client in New Brunswick, NJ to provide QA oversight for CMO batch records and release documentation within a cGMP environment.

The role involves reviewing GMP documents, coordinating with site teams, supporting FDA audits, CAPA management, and ensuring compliance with Quality standards. 5+ years in pharma/biotech QA is preferred; fluent English required.

Qualifications

• BS in Life Sciences or equivalent with 5+ years in pharma/biotech.
• Hands-on QA site or ExM operations with QA systems experience.
• Fluent in English.
• Familiar with cGMP, ICH, FDA guidance.
• Ability to coordinate QA oversight with site groups.

Responsibilities

• Provide QA oversight for CMO batch records.
• Review batch records and GMP documents for release.
• Assist with document control and QA functions.
• Coordinate timely review of documentation for CMO manufacturing.
• Assist with FDA audits and regulatory inspections preparation.
• Provide daily summaries and CAPA follow-up.
• Guide CMO to ensure compliance with client quality standards.
• Escalate critical quality problems to senior management.
• Support site inspections and QA readiness.
• Review quality events and CAPAs to ensure timely completion.
• Communicate with management and site staff.

Skills

English fluency

QA systems experience

cGMP knowledge

Regulatory audits

Documentation review

Education

BS in Life Sciences

Job description

Sapta is seeking a QA Specialist for our client in New Brunswick, NJ to provide QA oversight for CMO batch records and release documentation within a cGMP environment.

The role involves reviewing GMP documents, coordinating with site teams, supporting FDA audits, CAPA management, and ensuring compliance with Quality standards. 5+ years in pharma/biotech QA is preferred; fluent English required.