Quality Control Analyst II, Compliance

Job Description

The role of the Quality Control Analyst II 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.

• 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.

• Requires bachelor's degree in science, engineering, or other related technical field.
• 2-5 years of related experience in pharmaceutical or similar regulated industry.
• Experience with laboratory investigations in the GMP pharmaceutical industry preferred.

• Know 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 investigations.
• Possess excellent technical and interpersonal skills and be able to communicate with all level personnel and regulatory authorities.
• A advanced knowledge in cGMP standards, preferred.
• Strong problem-solving and analytical skills are required.
• Possess knowledge of core Quality Control principles and support systems.
• 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.
• Good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
• Self-driven individual that requires minimal supervision.
• Proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint).

• Onsite position with a schedule of Monday - Friday (day shift i.e. 8 AM - 5 PM)
• Prolonged periods sitting at a desk and working on a computer.
• Frequently or constantly to lift, carry push, pull, or move objects and repetitive motions.
• Work is performed in office and laboratory setting(s).
• Position requires a combination of sedentary work and walking around the facility.
• Non-Exempt roles must be able to work overtime when required.
• Some cleanroom and cool/hot storage conditions.
• May be required to enter controlled environments requiring special gowning.
• No makeup, no jewelry, contact lenses, nail polish, artificial fingernails may be worn in the manufacturing environment.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Takeda…