Quality Control Analyst

Astrix Inc

$72K — $104K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Chemistry or related scientific discipline with 6+ years of QC laboratory experience or equivalent education/experience.
  • Experience with investigations, root cause analysis, investigation writing, and CAPA identification.
  • Strong knowledge of cGMP requirements and laboratory quality practices.
  • Excellent problem-solving, documentation, and communication skills.

Responsibilities

  • Lead and document QC and OOS investigations from initiation through closure.
  • Conduct root cause analysis using 6M, 5 Why, and Fishbone methodologies.
  • Identify CAPAs and support corrective actions to prevent recurring issues.
  • Collaborate with QC, QA, customers, and cross-functional teams to meet investigation deadlines and quality commitments.
  • Ensure investigations comply with cGMPs, SOPs, and global quality standards.
  • Track laboratory metrics and identify opportunities to reduce analyst errors, equipment failures, and testing issues.
  • Provide investigation updates to management and support critical laboratory investigations.

Benefits

  • Work in a cGMP-regulated environment, enhancing compliance knowledge and skills.
  • Opportunity to lead important quality investigations, allowing for professional growth.
  • Collaborative work with cross-functional teams, fostering a team-oriented culture.
  • Engagement with a variety of quality-related methodologies and tools, enriching your skill set.
Full Job Description
Pay Rate Low: 35 | Pay Rate High: 50

Our client is seeking an experienced QC Analyst to support laboratory investigations, root cause analysis, and CAPA activities within a cGMP-regulated environment. This is a great opportunity for a quality-focused professional looking to take ownership of critical investigations and work closely with cross-functional teams.

Responsibilities
  • Lead and document QC and OOS investigations from initiation through closure.
  • Conduct root cause analysis using 6M, 5 Why, and Fishbone methodologies.
  • Identify CAPAs and support corrective actions to prevent recurring issues.
  • Collaborate with QC, QA, customers, and cross-functional teams to meet investigation deadlines and quality commitments.
  • Ensure investigations comply with cGMPs, SOPs, and global quality standards.
  • Track laboratory metrics and identify opportunities to reduce analyst errors, equipment failures, and testing issues.
  • Provide investigation updates to management and support critical laboratory investigations.

Qualifications
  • Bachelor's degree in Chemistry or a related scientific discipline with 6+ years of QC laboratory experience, or an equivalent combination of education and experience.
  • Experience with investigations, root cause analysis, investigation writing, and CAPA identification.
  • Strong knowledge of cGMP requirements and laboratory quality practices.
  • Excellent problem-solving, documentation, and communication skills.
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