Quality Control Analyst II

Takeda•Social Circle, GA

1d•Onsite

About The Position

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, including protocols, standard operating procedures (SOPs), and analytical methodologies and design and coordinate analytical method onboarding activities, including execution planning, training, and documentation. At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Requirements

Bachelor's degree in science, engineering, or other related technical field.
2-5 years of related experience in pharmaceutical or similar regulated industry.
Knowledge of quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs.
Ability to manage multiple tasks and responsibilities for the QC Lab.
Ability to manage complex projects and resolving complex lab issues.
Excellent technical and interpersonal skills and ability to communicate with all level personnel and regulatory authorities.
Strong leadership, project and people management skills, and ability to make critical decisions.
Strong understanding of business and/or industry.

Nice To Haves

Advanced knowledge in Statistical Analysis and cGMP standards

Responsibilities

Perform compendial assessments to ensure compliance with current regulatory requirements and pharmacopeial standards.
Author and review technical documents, including protocols, standard operating procedures (SOPs), and analytical methodologies.
Design and coordinate analytical method onboarding activities, including execution planning, training, and documentation.
Lead and manage the qualification of critical materials, ensuring fitness for use in analytical testing.
Oversee change control management processes, including risk assessment, documentation, and implementation.
Manage Corrective and Preventive Actions (CAPAs) related to analytical processes and support timely closure of quality events.
Act as a Subject Matter Expert (SME) by providing technical guidance and troubleshooting support to laboratory testing teams.
Collaborate effectively across departments to ensure alignment and successful execution of cross-functional initiatives.
Identify and drive continuous improvements in analytical methods and laboratory workflows to enhance efficiency and compliance.
Conduct data trending and analysis of laboratory processes and analytical performance on a routine basis to identify trends and areas for improvement.
Collaborate as a QC representative with global teams on both global and local projects and take the initiative for improvements.
All other duties as assigned by Leadership