Quality Assurance Manager

TCP Analytical; Holtsville (NY); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading chemical manufacturer in Holtsville, NY seeks a Manager of Quality to oversee product quality and ensure compliance with GMP and GFSI standards. Responsibilities include maintaining quality management systems, leading the quality team, and conducting audits. Ideal candidates will have 5+ years of quality experience, with a bachelor's degree in a related field, and strong problem-solving and leadership skills. Competitive salary and benefits are offered.

Qualifications

• 5+ years of experience in quality, with at least 1 year in a leadership role.
• Experience in a regulated industry such as manufacturing or pharmaceuticals.
• Strong understanding of quality assurance methods.

Responsibilities

• Maintain quality management system documentation and compliance.
• Oversee batch record release and raw materials management.
• Conduct investigations and drive process improvements in quality.

Skills

Quality assurance methodologies

Testing strategies

Problem-solving skills

Communication skills

Leadership

Attention to detail

Education

Bachelor’s degree in Chemistry, Engineering, or related field

Tools

ISO 9001

FDA regulations

GHS standards

Job description

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

About the Role

The Manager 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 GFSI (food requirements). This role involves leading the Quality 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

• Maintain quality management system documentation for current compliance with GFSI and FDA requirements.


• Oversee 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.


• Work closely with QC laboratory to ensure process/analysis consistency, support investigations such as OOS.


• Assist in plant production troubleshooting 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.


• 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 and across other TCP Analytical sites.


• Conduct investigations using root cause analysis tools, prepare corrective and preventive action plans, and implement action 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, manage, 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, 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.

Tangram is proud to be an equal opportunity employer.

Equal Opportunity Statement

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.