Quality Assurance Supervisor - TCP Analytical : Job Details

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$75,000.00/yr - $85,000.00/yr

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Human Resources Director, North America at TCP Analytical

About the Company

Tangram Chemical, a TCPA Company is a manufacturer of High Purity Inorganic Chemicals, and a provider of Custom Chemical Services.

About the Role

The Supervisor of Quality is responsible for overseeing and improving the quality of products and ensuring there is a quality management system in place to comply with GMPs (Good Manufacturing Practices) and ISO 9001. This role involves leading the QA and QC team, developing strategies to ensure compliance, and identifying areas for improvement in both processes and products. The Manager of Quality ensures that all products and services meet regulatory requirements, industry standards, and customer expectations.

Responsibilities

Quality Management System:

• Develop, implement and maintain quality management system documentation for current compliance with ISO 9001 and FDA requirements.
• Maintain quality compliance functions such as change control, stability program, validations, supplier management, risk management and ISO 9001 programs.
• Ensure customer complaints are investigated and responded to, as well as complete customer questionnaires.
• Monitor the USP, NF, EP, JP, and ACS for updates and incorporate updates as required.
• Host regulatory audits, surveillance audits and customer audits. Properly prepare for audits and respond to audits as needed.
• Perform or participate in internal audits at the site.

Process & Product Quality Control:

• Oversee the inspection and testing of raw materials, in-process products, and final product specifications are met.
• Work closely with production and QC chemist to ensure process consistency and product integrity / quality.
• Ensure validation program is in place and follows quality by design aspects for cGMP production.
• Oversee and execute batch record release, CofA generation, and act as reviewer when necessary to release production batches.
• Oversee receiving, sampling, quarantine, and release of raw materials as per procedures.
• Assist in plant production trouble shooting problems and actively work on resolution plans.
• Conduct investigations using root cause analysis tools, prepare corrective and preventive action plans, and implement actions plans accordingly.
• Support OOS (out-of-specification) investigations with the QC laboratory.
• Identify and drive process improvements within the QA function, working to streamline testing and improve product quality.
• Monitor industry trends, technologies, and best practices to continuously evolve the QA process.
• Identify potential quality risks early in the development process and work proactively to mitigate them.

Leadership, Collaboration and Reporting:

• Lead, manage, and mentor QA and QC team. Provide training, guidance, and support to team members to promote skill development and career growth.
• Collaborate with cross-site and cross-functional teams to support company goals and business objectives.
• Provide clear and concise quality reports to senior leadership, highlighting status progress, risks, and issues.
• Develop and maintain documentation related to QA procedures and policies.
• Support development activities including new product development and process improvements.
• Dotted line reporting structure to operations to support production operations activities and priorities.

Compliance and Standards:

• Ensure that all products and services meet regulatory and compliance requirements.
• Maintain knowledge of relevant industry standards and best practices (e.g., ISO, FDA, etc.) and integrate them into the QA processes.

Qualifications

• Education: Bachelor's degree in Chemistry, Engineering, or science related field.
• Experience: 5+ years of experience in quality, with at least 1 year in a leadership or managerial role. Experience in a regulated industry (e.g., manufacturing, pharmaceuticals, healthcare).
• Certifications (preferred): ISO 9001 Lead Auditor, or similar quality-related certifications.

Required Skills

• Strong understanding of quality assurance methodologies, testing strategies, and tools (manual and automated).
• Familiarity with relevant industry standards and regulatory requirements (e.g., ISO9001, FDA, USP, NF, FCC).
• Strong problem-solving skills and attention to detail.
• Excellent communication, leadership, and interpersonal skills.
• Ability to work cross-functionally and manage multiple priorities.

Equal Opportunity Statement:

Tangram is proud to be an equal opportunity employer. We are an Equal Employment. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesChemical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Disability insurance

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