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Quality Assurance Validation Jobs in Indiana (NOW HIRING)

Works with developers and chemists to ensure that all quality assurance requirements are captured in the correct electronic formats, with an emphasis on traceability and validation of a laboratory ...

... validations, etc.) * Assist as required with all other site QA activities not otherwise listed ... above. * Attend quality related meetings and conference calls. Interface with Corporate QA on ...

$55K - $65K/yr

Document, investigate, reproduce, track, and validate software defects, enhancement requests, and ... Contribute to continuous improvement of QA processes, testing standards, documentation, and release ...

The Area QA Manager role has a national salary range of $85,000- $150,000. DHL Supply Chain offers ... Manages the validation process (as applicable) at a sector or network level and associated change ...

Valid Driver's license in good standing with current automobile insurance. Other Skills and Abilities: * Knowledge and experience with quality assurance systems, quality control and/or performance ...

Valid Driver's license in good standing with current automobile insurance. Other Skills and Abilities: * Knowledge and experience with quality assurance systems, quality control and/or performance ...

The Area QA Manager role has a national salary range of $85,000- $150,000. DHL Supply Chain offers ... Manages the validation process (as applicable) at a sector or network level and associated change ...

Develop and maintain quality documentation, including process validation protocols, technical ... quality assurance/quality engineering in a medical device or related industry. * Strong ...

QA Manager I The QA Manager I role has a national salary range of $85,000- $150,000. DHL Supply ... Support validated processes as applicable for regulated hardware, equipment, and software systems.

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Quality Assurance Validation information

What is quality assurance validation?

Quality Assurance (QA) Validation is the process of ensuring that products, processes, or systems meet specified requirements and function as intended. It involves activities such as planning, executing, documenting, and reviewing tests to confirm that the final output is reliable, safe, and compliant with industry standards or regulations. QA Validation is crucial in industries like pharmaceuticals, manufacturing, and software, where quality and safety are paramount. The process helps prevent defects, reduces risks, and ensures customer satisfaction by delivering consistent and high-quality results.

What skills and qualifications are needed for quality assurance validation?

To thrive as a Quality Assurance Validation professional, you need a strong background in quality management systems, validation protocols, and regulatory compliance, often supported by a degree in science or engineering. Familiarity with industry standards like GMP/GLP, validation software, and documentation tools is typically required, along with certifications such as ASQ or Six Sigma. Attention to detail, analytical thinking, and effective communication are crucial soft skills for ensuring thorough validation processes and cross-functional collaboration. These competencies are essential to guarantee product quality, maintain regulatory compliance, and minimize risks in highly regulated industries.

How does a quality assurance validation professional collaborate with cross-functional teams during product development?

Quality Assurance Validation professionals frequently work alongside teams such as research and development, manufacturing, and regulatory affairs to ensure that products meet required quality and compliance standards. Their role often involves reviewing documentation, participating in risk assessments, and coordinating validation activities like protocol drafting and execution. Effective communication and collaboration are key, as they must align validation processes with project timelines and address any compliance issues that may arise. By fostering strong cross-functional relationships, QA Validation specialists help ensure products are safe, effective, and meet regulatory requirements.

What is the difference between Quality Assurance Validation vs Quality Control Inspector?

AspectQuality Assurance ValidationQuality Control Inspector
Primary FocusEnsuring validation processes and systems meet regulatory standardsInspecting products for defects and compliance
CertificationsGMP, ISO, validation-specific trainingQuality inspection certifications, such as CQI
Work EnvironmentLaboratories, validation labs, manufacturing plantsManufacturing lines, warehouses, inspection stations
Employer & IndustryPharmaceuticals, biotech, medical devicesManufacturing, food production, electronics

While both roles aim to ensure product quality, Quality Assurance Validation focuses on validating systems and processes to meet standards, whereas Quality Control Inspectors perform direct product inspections to identify defects. Both are essential for compliance and quality but serve different stages in the quality management process.

What cities in Indiana are hiring for Quality Assurance Validation jobs?

Cities in Indiana with the most Quality Assurance Validation job openings:

Manager, QA Validation Oversight

Rensselaer, IN • On-site


Regeneron Pharmaceuticals
Biotechnology Research and Development • 5 - 10K employees

8.5

Company rating: 8.5 out of 10

Based on 44 frontline employees who took The Breakroom Quiz

19th of 86 rated pharmaceutical

Good employer

Recommended by parents

Respectful managers


$90K - $173K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 3 days ago


Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, QA Validation Oversight to lead a team dedicated to ensuring the integrity of our process validation processes. This role is integral in supporting process validation activities, ensuring global consistency, addressing recurring themes in process documentation, and playing a pivotal role in regulatory inspections and compliance.

When & where:

  • Location: Rensselaer, NY

  • Work model: Monday-Friday, 8am-4:30pm

Discover your role:

  • Ensuring alignment between validation activities and Process Sciences initiatives to support successful transition of processes from development to manufacturing.

  • Collaborate closely with internal Process Sciences team to provide technical expertise and ensure consistency in Process Validation strategies.

  • Presenting/defending validation strategies, documentation, and processes to FDA and other regulatory agencies.

  • Reviewing and approving process validation documents, procedures, and protocols, proposing modifications and corrections where necessary to meet regulatory requirements and expectations.

  • Overseeing all aspects of QA Validation including review and approval of failure investigations, change controls, SOPs, Validation protocols and summary reports, and validation master plans.

  • Conduct one-on-one discussions with team members to review their performance feedback and set development goals, fostering professional growth within the team.

This role requires:

  • Bachelor's degree in Engineering, Chemistry, or Life Sciences degree, or equivalent combination of education and experience, and the following amount of relevant work experience for each level:

    • Associate Manager: 6+ years

    • Manager: 7+ years

    • Level will be determined based on experience

  • Hands-on validation experience in a GMP-regulated environment

  • Deep understanding and expertise in Process Validation

  • Enjoying building strong, collaborative relationships across global internal teams

  • A continuous improvement mindset

  • Leadership skills that inspires and guides a multi-tiered team

#REGNQA

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.


Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed onsite. Please speak with your recruiter and hiring manager for more information about onsite expectations for your role and location.


As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.


For jobs in Canada: this posting is for an existing position.


Salary Range (annually)

$90,800.00 - $173,400.00


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