Quality Manager

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 Quality Manager is responsible for ensuring there is a quality management system in place to comply with GMPs (Good Manufacturing Practices) and GFSI (food requirements). This role involves leading the Quality team, maintaining compliance, and implementing continuous improvement. The Quality Manager ensures that all products and services meet regulatory requirements, industry standards, and customer expectations.

Responsibilities

• Maintain quality management system documentation for current compliance with GFSI and FDA requirements.
• Host regulatory audits, surveillance audits and customer audits. Properly prepare for audits and respond to audits as needed.
• Support and oversee batch record release, CofA generation, and act as reviewer when necessary to release production batches.
• Work closely with QC laboratory to ensure process / analysis consistency, support investigations such as OOS.
• 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.
• Maintain quality compliance functions such as change control, stability program, validations, supplier management, risk management and GFSI programs.
• Ensure customer complaints are investigated and responded to, as well as complete customer questionnaires.
• Monitor the USP, NF, ACS and FCC for updates and incorporate updates as required.
• Perform or participate in internal audits at the site and across other TCP Analytical sites.

Continuous Improvement

• Lead continuous improvement projects to fruition and collaborate with cross functional and cross site teams.
• 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 quality function, working to streamline testing and improve product quality.
• Monitor industry trends, technologies, and best practices to continuously evolve the quality process.
• Identify potential quality risks early in the development process and work proactively to mitigate them.

Leadership, Collaboration and Reporting

• Lead, supervise, and mentor quality 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 quality procedures and policies.

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 quality processes.

Qualifications

• Education: Bachelor’s degree in chemistry, Engineering, or science related field.
• Experience: 5 years of experience in quality assurance, with at least 2 years 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. PCQI training certification (Prevent Controls for Human Food).

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., GFSI, 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.

Preferred Skills

• Experience in a regulated industry (e.g., manufacturing, pharmaceuticals, healthcare).

Equal Opportunity Statement

TCPA 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.