Quality Control Analyst II
Takeda
August 06, 2026
On-site
Social Circle, GA
$71,800 - $112,860 USD yearly
Operations
About the role:
As a Quality Control Analyst II, you will perform compendial assessments to ensure compliance with current regulatory requirements and pharmacopeial standards. You will author and review technical documents (protocols, SOPs, analytical methodologies) and design and coordinate analytical method onboarding activities (execution planning, training, documentation).
How you will contribute:
- Lead and manage qualification of critical materials for analytical testing.
- Oversee change control processes (risk assessment, documentation, implementation).
- Manage CAPAs related to analytical processes and support timely closure of quality events.
- Serve as a Subject Matter Expert (SME) providing technical guidance and troubleshooting to laboratory testing teams.
- Collaborate across departments to ensure alignment on cross-functional initiatives.
- Drive continuous improvements in analytical methods and laboratory workflows for efficiency and compliance.
- Conduct routine data trending and analysis of laboratory processes and analytical performance.
- Collaborate with global teams as a QC representative on global/local projects and lead improvement initiatives.
- Other duties as assigned by Leadership.
What you bring to Takeda:
- Bachelor’s degree in Chemistry, Biology, Microbiology, Engineering, or related scientific discipline with 2–5 years of GMP-regulated lab experience.
- Experience with laboratory quality systems: change controls, CAPAs, investigations, technical documentation.
- Knowledge of analytical method lifecycle activities (implementation, onboarding, validation, or transfer).
- Strong understanding of cGMP and pharmaceutical quality systems.
- Statistical analysis and data trending using tools such as Microsoft Excel or Minitab.
- Preferred: environmental monitoring programs or laboratory quality metrics.
- Plus: Power BI, Power Automate, or similar tools.
- Excellent project management, organizational, and technical writing; ability to manage multiple priorities.
- Strong communication/collaboration across QC, Manufacturing, Engineering, Validation, and Regulatory.
Application instructions:
By clicking the “Apply” button, I understand the employment application process will commence and my information will be processed per the company’s Privacy Notice and Terms of Use; I attest that submitted information is true.
As a Quality Control Analyst II, you will perform compendial assessments to ensure compliance with current regulatory requirements and pharmacopeial standards. You will author and review technical documents (protocols, SOPs, analytical methodologies) and design and coordinate analytical method onboarding activities (execution planning, training, documentation).
How you will contribute:
- Lead and manage qualification of critical materials for analytical testing.
- Oversee change control processes (risk assessment, documentation, implementation).
- Manage CAPAs related to analytical processes and support timely closure of quality events.
- Serve as a Subject Matter Expert (SME) providing technical guidance and troubleshooting to laboratory testing teams.
- Collaborate across departments to ensure alignment on cross-functional initiatives.
- Drive continuous improvements in analytical methods and laboratory workflows for efficiency and compliance.
- Conduct routine data trending and analysis of laboratory processes and analytical performance.
- Collaborate with global teams as a QC representative on global/local projects and lead improvement initiatives.
- Other duties as assigned by Leadership.
What you bring to Takeda:
- Bachelor’s degree in Chemistry, Biology, Microbiology, Engineering, or related scientific discipline with 2–5 years of GMP-regulated lab experience.
- Experience with laboratory quality systems: change controls, CAPAs, investigations, technical documentation.
- Knowledge of analytical method lifecycle activities (implementation, onboarding, validation, or transfer).
- Strong understanding of cGMP and pharmaceutical quality systems.
- Statistical analysis and data trending using tools such as Microsoft Excel or Minitab.
- Preferred: environmental monitoring programs or laboratory quality metrics.
- Plus: Power BI, Power Automate, or similar tools.
- Excellent project management, organizational, and technical writing; ability to manage multiple priorities.
- Strong communication/collaboration across QC, Manufacturing, Engineering, Validation, and Regulatory.
Application instructions:
By clicking the “Apply” button, I understand the employment application process will commence and my information will be processed per the company’s Privacy Notice and Terms of Use; I attest that submitted information is true.