Quality Assurance Validation Associate

Regulatory Toolkit; Thousand Oaks (CA); On-site; USD 72,000 - 113,000; Full time

Job summary

Takeda in Thousand Oaks, CA is seeking a Quality Assurance Validation Associate to ensure regulatory validation requirements are met across facilities and systems. You will review validation documents, master plans, IQ/OQ/PQ/CSV, and change controls while supporting regulatory submissions and audits.

Responsibilities include risk assessment, traceability, and guiding QA processes in line with GMP/GxP standards. Local gowning, PPE, and other controlled-environment requirements apply as needed.

Qualifications

• Bachelor’s Degree in Biotechnology, Microbiology, Pharmacy or equivalent.
• Minimum 5 years in pharmaceutical/biopharmaceutical validation.
• Experience writing and executing validation protocols.

Responsibilities

• Review validation documents for accuracy and regulatory compliance.
• Review Validation Master Plans and IQ/OQ/PQ/CSV packages.
• Provide QA support for facility, utilities, systems, process, and computer systems validation.

Skills

GxP knowledge

Cross-functional teamwork

Regulatory compliance

Education

Bachelor’s degree in Biotechnology, Microbiology, Pharmacy or equivalent

Advanced degree (preferred)

Tools

Veeva

Kneat

ALM

Job description

Job Description

About the role:

As a Quality Assurance Validation Associate, you will work as part of cross-functional teams providing quality oversight, review, and approval of validation deliverables and change controls to ensure that products and processes meet appropriate regulatory agency validation requirements, internal company standards and current industry practices. This position will typically focus on disciplines related to facilities, utilities, equipment, process qualification, cleaning, QC methods and instruments, computer systems validation and data integrity.

How you will contribute:

• Responsible for reviewing validation documents, against Standard Operating Procedures (SOPs) for accuracy and compliance with procedures, based on regulatory requirements and internal guidelines.
• Review from a quality perspective the validation documentation required to assure the proper development of a project and support regulatory submissions.
• Responsible for reviewing Validation Master Plans, Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification, Computer System Validation, and Validation Maintenance packages in accordance with existing procedures. Reviews deliverables for compliance with existing requirements. Approves documentation related to system decommissioning.
• Provide validation expertise and support for the development (or modification phases) of manufacturing facility, utilities, systems, process and information and Computerized System; address, include and implement all the applicable QA requirements.
• Participate in the risk assessment related to the project.
• Assure requirements traceability throughout the whole project life cycle.
• Provide support in all quality-related issues, including GMP regulations
• Assess and approve Change controls, CAPAs and deviations to ensure conformance to regulatory agency requirements, company standards and industry best practices
• Take part in internal/external audits.
• Maintain project metrics to communicate risk trends and implementation readiness to support project timelines and commercial readiness
• May perform other duties as assigned.

What you bring to Takeda:

• Bachelor’s Degree in Biotechnology, Microbiology, Pharmacy or equivalent is strongly preferred.
• Minimum of 5 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment, or an advanced degree.
• Experience in pharmaceutical/biotech validation which includes the writing and executing of protocols.
• Proficiency in electronic document management systems (e.g. Veeva, Kneat, ALM)
• Strong knowledge of US GMP/EU regulations and GxP guidelines.
• Extensive cross-functional team experience, including technical and non-technical work.

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.
• In general, position requires both sedentary work and walking through facility
• Wrist and hand motion (typing, writing)
• Must be able to occasionally visit controlled or clean room environments requiring gowning. May be required to wear personal protective equipment (PPE) and other clean room garments daily (may include safety shoes, safety glasses, lab coats, full body gowns, goggles, hair covers, and gloves. No make-up, jewelry, contact lenses, nail polish, or artificial nails may be worn in these environments.
• Although assignments will be made specific to working hours, flexibility is expected, with the understanding that there may be changes in work hours, duties, and responsibilities.

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 - CA - Thousand Oaks - Rancho Conejo

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 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.

For information about our benefits, please click here.

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

Yes