Tester at Sapta Global Inc Signal Hill, CA

Sapta Global Inc; 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

Job Description Job Description Tester Salary$25 an hourJob TypeContract Be part of a company that delivers life-changing healthcare solutions. Sapta is looking for a QA Specialist for our client in New Brunswick, NJ.Sapta’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Position Overview:

This role is an 18 to 24 month opportunity to gain experience with Bulk Drug Substance manufacturing. The Senior Quality Assurance Specialist will provide Quality oversight to the CMO with the ability to be on site up to support Quality Reviews and QA Shop Floor manufacturing support. You will manage CMO oversight for change management, deviation management, Annual Product Quality reports, Quality Agreements, Risk Assessments and CMO product release. This position may also be cross trained to cover other QA functions as needed.

Responsibilities:

• Provides oversight for CMO Batch Production Records.
• Reviews executed Batch Records, GMP documents and prepare documentation for product release/disposition.
• Assists with Document Control and other QA functions.
• Coordinates and assist in timely review of documentation associated with manufacturing at CMO site.
• Assists with preparation for FDA and other regulatory agency audits and inspections.
• Provides daily summaries and follows the completion of CAPAs from audit findings.
• Gives guidance to CMO as needed and ensure CMO is compliant with Client Quality standards.
• Ensures that all audit items are resolved.
• Supports site for Inspection.
• Reviews any Quality Events, CAPAs from internal and external audits to ensure that actions necessary to provide adequate confidence that the cGMP requirements are completed on time.
• Escalates critical quality problems to Senior Management in a timely manner.

Qualifications:

• BS in Life Sciences or equivalent with 5+ years related experience within a pharmaceutical or Biotechnology Company.
• Hands-on QA Site or ExM Operations / QA Systems experience including supporting Validations within pharmaceutical or Biotechnology Company.
• Must be fluent in English language.
• Additional experience in an area allied with cGMP Quality, Quality Systems, Biopharma Production Processes, 21CFR 210-211, ICH guidelines, FDA Guidance for Industry for Investigating OOS Results, Deviations, CAPAs, Validation, Stability Studies, QC laboratory operations and manufacturing operations, auditing is preferred.
• Ability to Coordinate Quality oversight and working with other site groups.
• Ability to review Quality documents and ensuring compliance to GMP.
• Documents to include batch records, logs, and others.
• Ability to be an effective communicator to Management, and line staff.
• Ability to work with other manufacturing teams to implement business objectives.
• Must be very detail oriented and be able to quickly detect errors within documentation.