Quality Control Manager jobs in United States
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Astrix ยท 2 hours ago

Quality Control Manager

Astrix is seeking a seasoned Quality Control Manager to establish and maintain robust quality frameworks for cosmetic and over-the-counter skincare products. The role focuses on upholding regulatory compliance and ensuring inspection preparedness for OTC formulations, including sun protection products.

ConsultingInformation Technology
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Growth Opportunities
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H1B Sponsor Likelynote
Hiring Manager
Elise Gasson
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Responsibilities

Direct the quality assurance function ensuring adherence to federal regulations and organizational quality benchmarks
Design, implement, and maintain quality management systems aligned with current regulatory frameworks
Orchestrate preparation for and execution of regulatory inspections, serving as primary liaison with federal investigators
Maintain state of readiness for unannounced regulatory visits
Provide quality guidance for new drug application processes related to OTC products, with emphasis on topical sun protection formulations
Collaborate on regulatory submission documentation ensuring quality data integrity
Review and authorize batch production records, deviation investigations, corrective and preventive action plans, standard operating procedures, and change control documentation

Qualification

Quality Management SystemsFDA Audits21 CFR RegulationsMOCRA ComplianceNDA SubmissionsBachelor's DegreeLeadership Skills

Required

Bachelor's degree in Chemistry, Biological Sciences, Pharmaceutical Sciences, or related scientific discipline
Proven experience as a QC Manager or Quality Manager within a cosmetic or OTC product company
Direct experience participating in and leading FDA audits
Strong working knowledge of 21 CFR regulations
Hands-on experience with MOCRA compliance
Experience supporting NDA submissions for OTC products, particularly sunscreens

Company

Astrix

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Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.

H1B Sponsorship

Astrix has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (9)
2023 (10)
2022 (16)
2021 (11)

Funding

Current Stage
Late Stage

Leadership Team

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Dale Curtis
Chief Executive Officer
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Reid E. Simpson
Chief Financial Officer
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Company data provided by crunchbase