QC Lab tech/Regulatory Assistant

About the position

The QC Lab tech/Regulatory Assistant plays a vital role in ensuring that manufacturing processes comply with regulatory requirements and meet the company's quality standards. This position involves overseeing various aspects of QC, QA, Regulatory and Engineering, including Good Manufacturing Practices (GMP), quality systems, and corrective actions, to maintain high-quality production and compliance.

Responsibilities

• Ensure compliance with GMP regulations throughout the manufacturing process.
• Prepare documents, such as a safety data sheet (SDS) and ingredient list, for approval by relevant government agencies or regulatory bodies.
• Conduct regular audits and inspections to verify adherence to GMP standards.
• Develop and implement strategies to continuously improve GMP compliance.
• Maintain and improve the company's quality management system (QMS).
• Identify areas for process improvement and implement effective quality control measures.
• Collaborate with cross-functional teams to ensure alignment with quality objectives.
• Develop CAPA plans to address root causes and prevent recurrence of quality issues.
• Monitor and track the implementation of CAPAs to ensure effectiveness.
• Investigate deviations from established procedures and specifications.
• Document deviations and assess their impact on product quality.
• Develop and implement corrective actions to address deviations and prevent recurrence.
• Establish and maintain document control procedures for quality documents.
• Ensure the accuracy, completeness, and integrity of quality-related documentation.
• Manage document change control processes and maintain document repositories.
• Develop, review, and update SOPs to reflect current best practices and regulatory requirements.
• Ensure SOPs are followed consistently throughout the organization.
• Provide training and support to employees on SOPs and quality processes.
• Help develop, implement and maintain QC systems and measures.
• Designs and implements testing procedures, conducts inspections, and identifies any deviations from established standards.
• Conduct quality inspections on raw materials, packaging materials and finished products.
• Evaluate packaging designs for compliance with brand standards and regulatory requirements.
• Collaborate with production teams to identify and resolve quality issues.
• Maintain detailed records of inspections, testing, and non-conformities.
• Lead and execute manufacturing engineering projects, including new equipment installation, process validation, and continuous improvement initiatives.
• Analyze existing manufacturing processes and develop strategies to improve efficiency, reduce waste, and minimize production downtime.
• Provide technical guidance to production personnel on process parameters, quality standards, and troubleshooting issues.
• Analyze manufacturing costs and identify opportunities for cost reduction through process optimization and material selection.
• Audit new suppliers and evaluate their technical capability and equipment suitability for our needs.

Requirements

• Bachelor's degree in a related field preferred (e.g., Quality Assurance, QC, Chemistry, Biology, Engineering).
• At least 2-5 years experience working in a manufacturing environment, preferably in a regulated industry (e.g., cosmetics, pharmaceuticals, medical devices, food).
• Strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements (e.g., FDA, ISO).
• Experience with quality systems management, CAPAs, deviations, document control, and SOPs.
• Excellent analytical and problem-solving skills.
• Effective communication and collaboration abilities.
• Must be able to read, write, and speak in English. Bilingual preferred.
• Detail-oriented with a commitment to quality and compliance.

Job Type: Full-time

Pay: $17.00 - $21.00 per hour

Benefits:

• Paid time off

Schedule:

• 8 hour shift
• Monday to Friday
• Morning shift

Work Location: In person