Regeneron
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We are hiring a Principal QA Validation Specialist to support the validation and qualification of computer systems within IOPS. The role involves planning, coordinating, and participating in the compliant computer system validation (CSV) process for systems that require formal validation documentation in accordance with regulatory and company manufacturing standards.
Responsibilities
Generates, executes, and/or reviews master and completed computer system qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
Analyzes testing results and determines acceptability against pre‑determined criteria.
Investigates and troubleshoots problems, identifying solutions or recommending changes and/or improvements.
Reviews, edits, and approves deviation notifications, deviation investigations, and corrective actions.
Reviews, edits, and approves change controls, SOPs, reports, and other documentation.
Coordinates with other departments or outside contractors/vendors to complete validation tasks.
Trains and advises less experienced specialists.
Leads projects and prepares status reports.
May be required to oversee contingent workers.
Qualifications
Thrive working in a quality‑driven environment.
Knowledge in GAMP, 21 CFR Part 11, and Annex 11.
Continuously aim to improve processes for enhanced performance.
Gather and organize information efficiently.
Meet commitments on time.
Follow directions and perform well‑defined tasks.
Experience & Education
Hold a BS/BA in Engineering, Chemistry, Life Sciences, Computer Science, IT, or a related field.
Principal QA Validation Specialist: 8+ years of experience (may substitute proven experience for educational requirement).
Benefits We offer a comprehensive benefits package, including health and wellness programs (medical, dental, vision, life and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves such as military and parental leave for eligible employees.
Salary Salary Range (annually) : $78,700.00 – $150,600.00
Equal Opportunity Employment Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
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We are hiring a Principal QA Validation Specialist to support the validation and qualification of computer systems within IOPS. The role involves planning, coordinating, and participating in the compliant computer system validation (CSV) process for systems that require formal validation documentation in accordance with regulatory and company manufacturing standards.
Responsibilities
Generates, executes, and/or reviews master and completed computer system qualification and validation protocols, summary reports, and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
Analyzes testing results and determines acceptability against pre‑determined criteria.
Investigates and troubleshoots problems, identifying solutions or recommending changes and/or improvements.
Reviews, edits, and approves deviation notifications, deviation investigations, and corrective actions.
Reviews, edits, and approves change controls, SOPs, reports, and other documentation.
Coordinates with other departments or outside contractors/vendors to complete validation tasks.
Trains and advises less experienced specialists.
Leads projects and prepares status reports.
May be required to oversee contingent workers.
Qualifications
Thrive working in a quality‑driven environment.
Knowledge in GAMP, 21 CFR Part 11, and Annex 11.
Continuously aim to improve processes for enhanced performance.
Gather and organize information efficiently.
Meet commitments on time.
Follow directions and perform well‑defined tasks.
Experience & Education
Hold a BS/BA in Engineering, Chemistry, Life Sciences, Computer Science, IT, or a related field.
Principal QA Validation Specialist: 8+ years of experience (may substitute proven experience for educational requirement).
Benefits We offer a comprehensive benefits package, including health and wellness programs (medical, dental, vision, life and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves such as military and parental leave for eligible employees.
Salary Salary Range (annually) : $78,700.00 – $150,600.00
Equal Opportunity Employment Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company’s business.
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