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Job Description

About the role:

As a Quality Analyst II, you will provide Quality support and oversight through direct staff supervision or process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and the company quality practices. You may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, Laboratory Operations. You will be a support function to manufacturing operations and is required to coordinate testing activities and communication of results with IG, Fractionation, and Albumin. Also, you will also correspond with other support departments such as QA, Engineering, Maintenance. You may participate in interdepartmental teams and communicate with different levels of personnel including management and site leadership.

The hours of this position are 10AM-8PM, Thursday-Sunday; weekend and holiday work. Overtime may be required.

How you will contribute:

Leads ongoing, daily departmental operations.
May include the guidance of assigned personnel in achieving defined quality goals. Interview/hire, evaluate, train, and develop direct reports.
Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude. Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques. Determine the logic, adequacy and effectiveness of systems and related requirements. Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.
Write, review, analyze, and revise written Standard Operating Procedures (SOPs) and submit procedural changes to meet Corporate, Divisional, Plant, Regulatory Requirements.
Navigate, answer alerts and review Batch Records in EBM.
Provide necessary floor support to the manufacturing teams and help in resolving compliance concerns.
Support external audits.
Help with audits of multiple reports (Protocols, Qualifications, Regulatory Submissions)
Be a Subject Matter Expert (SME) and provide training to local employees on relevant area(s).
Identify when proper practices/ procedures are not performed. Follow SOPs and identify processes and results.
Implement changes and corrections. Escalate accordingly. Ensure communication of issues.
Ensure communications between personnel, groups, and between departments.
Coordinate activities and schedules staff.

What you bring to Takeda:

Requires bachelor's degree in science, engineering or other related technical field. 3+ years of related experience.
Proficient in wet and instrumental methods of analyses.
Advanced laboratory skills and basic knowledge of statistical method.
Must demonstrate effectiveness in ability to train others.
Knowledge of most laboratory equipment including autoclaves, incubators and analytical equipment.
Must be proficient in multiple mathematical operations and calculations and be able to work with both the metric and US standards of measurements.
Will read and follow detailed written instructions and have good verbal/written communication skills.
Knowledge of basic chemical and biological safety procedures.
Knowledge of Microsoft 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:

In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility.
May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
Need to remove all make-up, jewelry, contact lenses, nail polish and 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,.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
Must be able to lift, push, pull and carry up to approximately 25lbs.
Will work in controlled environments requiring special gowning. Will follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
Will work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.
May work or be assigned to a different shift to meet needs. Must be willing to work off shifts hours.
Will work supplemental hours to complete work commitments.
May be required to work in a confined area.
Inside working conditions.
Some clean room and cool/hot storage conditions

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-Onsite

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 278

U.S. Base Salary Range:

67,900.00 - 106,700.00

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-termincentives. 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 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

Learn more about this Employer on their Career Site

Quality Control Analyst II