Quality Control Analyst II, Compliance

Takeda • Social Circle, GA

1d • $71,800 - $112,860 • Onsite

About The Position

As a Quality Control Analyst II for QC Compliance, the role is to provide technical expertise and support for the Operational Support functions of the QC Laboratory through ownership and participation in Quality Record management activities.

Requirements

• Requires bachelor's degree in science, engineering, or other related technical field.
• 2-5 years of related experience in pharmaceutical or similar regulated industry.
• Must know quality laboratory operations and government regulations pertaining to pharmaceutical and medical device manufacturing labs.
• Must have the ability to manage multiple tasks and responsibilities for the QC Lab.
• Must have the ability to manage complex investigations
• Must possess excellent technical and interpersonal skills and be able to communicate with all level personnel and regulatory authorities.
• Strong problem-solving and analytical skills are required.
• Possess knowledge of core Quality Control principles and support systems.
• Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross-functional teams and management on recommended courses of action, with minimal assistance.
• Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
• Self-driven individual that requires minimal supervision.
• Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint).

Nice To Haves

• Experience with laboratory investigations in the GMP pharmaceutical industry preferred
• Advanced knowledge in cGMP standards, preferred.

Responsibilities

• Author and revise GMP documents and Quality Control records (e.g. Test Methods, SOPs, change controls, etc.)
• Train staff in general Quality Control activities and updates
• Train staff in Deviation and Laboratory Investigation processes and techniques
• Collaborate in the mitigation of any environmental, Health, and Safety (EHS) needs and risks
• Identify and implement improvement initiatives to improve yield, reliability, and/or process robustness. This may require leading and implementing change controls.
• Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capability.
• Responsible for organizing data and preparing appropriate documentation, including presentation materials, for assigned projects.
• Lead any CAPA investigations
• Lead problem solving and root-cause analysis sessions
• Perform GEMBA and other information gathering techniques to support investigation completion and laboratory continuous improvement
• Interact with Quality, Manufacturing, Engineering and Tech Service units
• Manage complex investigations using DMAIC tools
• Ensure effective implementation of corrective and preventive actions
• All other duties as assigned by Leadership

Benefits

• medical insurance
• dental insurance
• vision insurance
• a 401(k) plan and company match
• short-term disability coverage
• long-term disability coverage
• basic life insurance
• a tuition reimbursement program
• paid volunteer time off
• company holidays
• well-being benefits
• up to 80 hours of sick time (per calendar year)
• up to 120 hours of paid vacation (for new hires)
• short-term and/ or long-term incentives (U.S. based employees may be eligible)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees