Quality Control Analyst II, Compliance

About the role

Provide technical expertise and support for the Operational Support functions of the QC Laboratory through ownership and participation in Quality Record management activities.

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, which 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
• Organize data and prepare appropriate documentation, including presentation materials, for assigned projects
• Lead 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

Requirements

• 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

Skills

• 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 investigations
• Excellent technical and interpersonal skills; ability to communicate with all level personnel and regulatory authorities
• Advanced knowledge in cGMP standards, preferred
• Strong problem-solving and analytical skills
• 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 ability to work effectively and efficiently in a team-based environment
• Self-driven individual that requires minimal supervision
• Proficient computer skills and experience using MS Office software (Word, Excel, and PowerPoint)

Other Job Requirements

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

About Takeda

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.

Pay

U.S. Base Salary Range: $71,800.00 - $112,860.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

Benefits

• Eligibility for short-term and/or long-term incentives
• Medical, dental, and vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Up to 80 hours of sick time per calendar year
• New hires are eligible to accrue up to 120 hours of paid vacation per calendar year

Schedule

Full time, Monday - Friday (day shift, 8 AM - 5 PM).