Quality Control Analyst II, Compliance
Social Circle, GeorgiaAs a trusted global leader and industry partner who is reimagining plasma and exploring its untapped potential, Takeda’s Plasma-Derived Therapies (PDT) Business Unit is dedicated to transforming the lives of patients worldwide who rely on these lifesaving and life-sustaining therapies.
With an 80-year legacy of developing treatments for rare and complex chronic diseases, we thrive on innovation, offering a broad, differentiated portfolio of more than 20 plasma medicines with integrated care solutions to patients in more than 80 countries.
Powered by ~ 17,000 Takeda employees, our ~230 high-quality BioLife donation centers, a dedicated R&D team, and eight world-class plasma manufacturing facilities, we are unleashing data, digital and technology to transform our end-to-end operations and set new industry standards.
This enables us to innovatively and sustainably meet the growing and changing needs of patients, our people, and our planet, today and in the future.
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About the role:
As a Quality Control Analyst II for QC Compliance 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.
How you will contribute:
- 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
What you bring to Takeda:
- 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
- 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.
- Advanced knowledge in cGMP standards, preferred.
- 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).
Important Considerations:
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. In this role, you may:
- Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
- Work in a cold, wet environment.
- Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
- 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 settings.
- 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 maybe 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.
#GMSGQ #ZR1 #LI-MA1
Takeda Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - GA - Social Circle - Hwy 278U.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 for the position, 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. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations
USA - GA - Social Circle - Hwy 278Worker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeJob Exempt
YesSuccess profile
What makes a successful team member within PDT at Takeda?
- Bold thinker
- Systematic
- Innovative
- Collaborator
- Agile
- Tenacious
Our Los Angeles facility
Changing lives with plasma-derived therapies
Working at Takeda
-
Inclusion
Here, you will feel welcomed, respected, and valued as a vital contributor to our global team. -
Collaboration
A strong, borderless team, we strive together towards our priorities and inspiring mission. -
Innovation
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients. -
Great Place to Work
Recognized for our culture and ways of working, we’re proud to be Certified as a Great Place to Work® in 25 countries and regions. -
Work-Life
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family. -
Empowerment
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Patient
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
People
Create an exceptional people experience.
Planet
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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