Quality Assurance Specialist II - Batch Release

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Job Description

Job Title : Quality Analyst II

Location : Thousand Oaks, CA

About the role :

You will perform the daily quality operations for product Batch Disposition within the Quality organization. You will identify and assess quality risks in activities and processes according to regulatory agency rules, guidelines, and Takeda quality practices.

You will assess critical criteria related to product batch disposition to ensure adherence to lead times.

How you will contribute :

• Responsible for verification of Manufacturing documentation against Standard Operating Procedures (SOPs) for accuracy, compliance to procedures based on regulatory requirements and internal guidelines, and acceptance criteria as part of the batch records release process.
• Identify areas of nonconformance and escalate to management (Manufacturing and Quality) for initiation of a Deviation.
• Administer and maintain relevant databases, prepare, and issue reports defined by the area, and develop custom reports.
• Help with external and internal audits / inspections by maintaining audit records, extracting data from databases, creating reports, collecting relevant data.
• Audit / review documents for completeness, CGMP's, company procedures and verification of data. Correct any deficiencies found.
• Maintain departmental business indicators and prepare metrics for the Management Review of Quality Systems.
• Conduct and perform investigations for non-conformances within respective area. Help identify corrective actions to prevent recurring non-conformances.
• Help with the development, and revision of SOPs to support Division Procedure Compliance and continuous improvement efforts.
• Improve projects within the department for efficiency and compliance related to the disposition process and related processes.
• Assist and prepare technical reports (e.g., YBPR)
• Help train Quality team members.
• Support internal / external inspections / audits as SME.
• Support process with closure of observations / audit items.
• Be a team member and help with CAPA Investigations for issues within respective area.
• Apply problem solving tools and methods to lead investigation teams.
• Knowledge of FDA regulations, Application of Good Laboratory Practices and Application of Good Manufacturing Practices and Good Documentation Practices.

What you bring to Takeda :

• High school diploma or equivalent required.
• Associate degree in a scientific discipline or bachelor's degree in a scientific discipline.
• 3 to 5 years of related work experience.

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. You may :

• The physical exertion of this position is sedentary.
• May walk occasionally when retrieving batch records from the records vault, attending meetings, and visiting the manufacturing areas for observation.
• Normal office environment; inside working conditions.
• 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.

• Will need to remove all make-up, jewelry, contact lenses, nail polish and / or artificial fingernails while in the manufacturing environment.
• May work in a cold, hot or wet environment.
• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Required to work 5 days a week, 8-hour days.
• May require overtime, weekend, and holiday work to support production.
• May work or be assigned to a different shift as needed.

More about us :

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs.

Takeda is a patient-focused company to 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

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 - CA - Thousand Oaks - Rancho Conejo

U.S. Hourly Wage Range :

$26.92 - $42.31

The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 hourly wage 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 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 - CA - Thousand Oaks - Rancho Conejo

Worker Type Employee

Worker Sub-Type Regular

Time Type Full time

Job Exempt