Senior QA Specialist

AGC Biologics$95K — $115K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's/Master's in Life Sciences, Pharmacy, or related field
  • 3-5 years of experience in QA/project management in pharma/biotech
  • Familiarity with GMP regulations and project management methodologies
  • Strong communication skills, capable of effective stakeholder engagement
  • Proficiency in project management tools (Jira, Aspera, MS Project) and document control systems (SharePoint, Document Vault)

Responsibilities

  • Oversee QA projects to ensure they align with quality and timeliness standards
  • Coordinate with cross-functional teams across QC, Regulatory, and other departments
  • Develop and implement project plans and timelines to track progress
  • Ensure adherence to GMP and other regulatory requirements
  • Identify potential project risks and develop mitigation strategies
  • Collaborate with stakeholders to manage project scope and changes
  • Support audits and other quality-related activities as needed

Benefits

  • Flexible working hours
  • Opportunity for career development within the organization
  • Work in a collaborative and supportive team environment
  • Access to ongoing training and professional development programs
  • Participation in company-sponsored health initiatives
Full Job Description
Job Title: Senior QA Specialist I
Reports to: Quality Assurance Manager/ Specialist II
Location: US-CRAN

Job Summary:
We're seeking an experienced QA Specialist to join our Quality Assurance team. The successful candidate will be responsible for leading QA projects, ensuring quality and timely delivery. Coordinate cross-functional teams, manage timelines, and ensure GMP compliance. Drive project success through effective communication and risk management.

Key Responsibilities:

- Oversee QA projects, ensuring timely completion and quality
- Coordinate cross-functional teams (QC, Regulatory and other relevant departments etc.)
- Develop and execute project plans, timelines
- Ensure compliance with GMP, regulatory requirements
- Identify and mitigate project risks, track progress
- Collaborate with stakeholders on project scope, changes

Support audits and other activities as required.

Requirements:

-Bachelor's/Master's in relevant field (e.g., Life Sciences, Pharmacy)
- 3-5 years in QA/project management, preferably in pharma/biotech
-GMP regulations, project management methodologies
-Strong communication, problem-solving, and organizational skills and Tools such as Project management: Jira, Aspera, MS Project, Document control: SharePoint, Document Vault ( any skill would be a plus)

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