On-the-Floor QA Specialist: GMP & Batch Release

Synectics Inc.

Redwood City (CA)

On-site

USD 90,000 - 130,000

Full time

12 hours ago
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Benefits offered by this job

Healthcare Insurance
Dental Insurance
Vision Insurance
401(k) Plan

Job summary

Synectics Inc. is seeking an on-floor QA support professional to guide technicians, ensure GDP/GMP batch record compliance, and approve material and product releases.

The role focuses on real-time cGMP adherence, SOP execution, and cross-functional QA collaboration. You will review batch records, participate in CAPA and change control, and ensure final disposition of materials and products while staying current with regulatory requirements.

Qualifications

  • Bachelor's degree required.
  • Hands-on cGMP pharma experience preferred.
  • Ability to work on manufacturing floor in PPE (PAPR).
  • Strong attention to detail and data integrity.

Responsibilities

  • Act as QA presence on the manufacturing floor for 7-8 technicians per shift.
  • Review and approve batch records and GMP documentation in SAP and related systems.
  • Release incoming materials and finished products per GDP/GMP.
  • Ensure SOPs and cGMP compliance in real-time production.
  • Collaborate with QA and PET to improve processes and risk assessments.

Skills

Attention to detail
Effective communication
Adaptability

Education

Bachelor's degree

Tools

SAP
Veeva EQV
GQCLIMS

Job description

Synectics Inc. is seeking an on-floor QA support professional to guide technicians, ensure GDP/GMP batch record compliance, and approve material and product releases.

The role focuses on real-time cGMP adherence, SOP execution, and cross-functional QA collaboration. You will review batch records, participate in CAPA and change control, and ensure final disposition of materials and products while staying current with regulatory requirements.

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