Quality Assurance Lead Coordinator jobs in United States
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Airswift · 2 weeks ago

Quality Assurance Lead Coordinator

Airswift is seeking a Quality Assurance Lead to work within our client's chemical facility in Port Neches, TX. This role is responsible for managing and continuously improving the Quality and Safety Management System (QMS), ensuring compliance with Good Manufacturing Practices (GMP) and relevant certifications.

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H1B Sponsor Likelynote

Responsibilities

Lead the implementation and maintenance of GMP practices across all operations
Ensure compliance with quality and safety standards, including ISO 9001, ISO 22716, ISO 14001, ISO 45001, RSPO, BRCGS, EXCiPACT, FSSC22000, EFfCI, Kosher, and Halal
Maintain current certifications and implement new ones aligned with business strategy
Develop and deliver training programs on quality standards and GMP requirements
Update and control the Document Management System
Develop and manage annual internal and external audit programs
Facilitate and lead audits, ensuring compliance with scope, objectives, and timelines
Oversee audit execution, review reports, and ensure closure of findings
Maintain a qualified audit team and engage external consultants as needed
Monitor audit trends and share insights with leadership
Manage the execution of the Validation Master Plan
Develop validation protocols for equipment, systems, cleaning, and CCPs
Ensure compliance with validation programs and revalidation requirements
Investigate non-conformities and perform root cause analysis
Lead local Quality & Product Safety Committees
Coordinate management reviews, recalls, and non-conformance teams
Define KPIs and drive continuous improvement initiatives
Implement and train risk analysis methodologies (FMEA & HACCP)
Qualify and monitor suppliers, supporting supplier audits
Manage customer quality documentation and agreements
Monitor regulatory developments, including FDA Foreign Supplier Verification Program

Qualification

GMP StandardsAudit LeadershipChemical ManufacturingISO StandardsRisk ManagementDocument Control SystemsLeadership SkillsCommunication Skills

Required

Subject Matter Expertise in GMP Standards (EXCiPACT, FSSC22000, BRCGS, etc.) with proven ability to lead GMP programs
Hands-on Experience in Facilitating and Leading Audits (internal and external)
Experience in Chemical Manufacturing Processes with strong understanding of quality and safety requirements
Minimum [X] years of experience in quality assurance within chemical or pharmaceutical manufacturing
Strong knowledge of ISO standards and risk management methodologies (FMEA, HACCP)

Preferred

Excellent leadership and communication skills
Ability to manage multiple projects and priorities
Proficiency in document control systems and audit management tools
Bachelor's degree in Chemistry, Chemical Engineering, Quality Assurance, or related field

Company

Airswift

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Airswift provides recruitment, employer of record and workforce solutions to STEM industries.

H1B Sponsorship

Airswift 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
2021 (1)

Funding

Current Stage
Late Stage
Total Funding
$49.91M
Key Investors
Palatine Private Equity
2012-10-05Acquired
2009-09-10Private Equity· $49.91M

Leadership Team

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Janette Marx
Chief Executive Officer
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Ian Langley
Chairman
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Company data provided by crunchbase