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Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at Takeda Pharmaceutical. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and integrity of our products.
Key Responsibilities- 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.
- Develop and implement corrective action plans to address identified risks.
- 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).
- Implement changes and corrections. Escalate accordingly. Ensure communication of issues.
- Ensure communications between personnel, groups, and between departments.
- Coordinate activities and schedules staff.
- 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.
This 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.
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.
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
About TakedaTakeda 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 278U.S. Base Salary Range:
$67, $106,700.00The 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.
