Quality Control and Regulatory Compliance Specialist- San Marcos, CA - Avista Membrane Treatment Solutions
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December 14, 2021

Quality Control and Regulatory Compliance Specialist- San Marcos, CA

Full-Time
San Marcos, CA
Posted 1 month ago

The Quality Control and Regulatory Compliance Specialist is a role within the Research and Development Department which reports directly to the Director of Research and Development. This individual will serve as a company-wide expert for planning, coordinating, monitoring and implementing regulatory strategies for products requiring domestic and/or international governmental approval. This role is also responsible for overseeing quality control and protocols to ensure all products produced to meet specific standards.

Main Areas of Responsibility:

Monitor and assess the regulations and changes globally regarding the business impact. This includes regulations that govern raw materials as well as finished products with focus on the regulations of chemicals, environment, occupational safety and consumer safety. Prepare and update summaries and online entries to meet regulatory requirements of regional and global requests in appropriate formats and share relevant information with the other departments of the organization. Research and stay ahead of regulatory trends and provide summaries from upcoming regulatory requirements which may affect future business or how products are transported. Oversee quality control within the company ensuring products conform to specifications before being shipped to customers. Follow protocols for products that do not conform to the quality control standards and communicate solutions to rectify the problem.

 

Specific job duties are as follows:

  1. Coordinate, support, and author clear and concise regulatory filings and responses for both domestic and international products.
  2. Review product labeling, including promotional material, product literature, and the company website for compliance with applicable regulations.
  3. Write or update SOPs related to the regulatory responsibilities and quality control of products.
  4. Participate in a systematic review of SOPs to ensure accuracy and compliance with directors.
  5. Maintain and update records of all regulatory filings and communications and product control documents in the internal database and prepare hard copies of documents for onsite inspections
  6. Maintain and update individual customer portals with appropriate information.
  7. Assist with consumer product safety initiatives including recalls and consumer product complaints.
  1. Help develop compliance training programs and deliver specialized training as appropriate.
  2. Ensure accuracy of labeling and certification.
  3. Responsible for reading, understanding and following Quality Systems documentation for each function performed.
  4. Providing technical assistance to managers and other operations staff, updating them on environmental standardization procedures, regulatory requirements, and work hazards prior to implementation.
  5. Maintain regulatory portals: EPA, CERS, CUPA, etc.
  6. Test and file results from product samples for conformity to quality control standards adding information to current data base and maintaining retain sample inventory
  7. Write or update SOPs related to the regulatory responsibilities and quality control of products.
  8. Investigate non-conforming product issues with Director of Product Development.
  9. Collaborate with shipping on providing necessary documentation globally.
  10. Provide regulatory or quality control documents to meet customer requests and identify when a NDA or confidentiality agreement is appropriate for the requested information to protect the company’s intangible assets.
  11. Monitor, Submit and update NSF approvals for existing and new products.
  12. Provide letters of compliance and or approvals when requested by customer or salesmen.
  13. Maintain and add products to the SDS/label software (Chemdox), keeping confidential and public files up to date.

Required Education and Experience:

  • Bachelors degree or higher in chemistry, manufacturing, regulatory science or related degree
  • 3-5 years experience in translation of chemical, environmental and safety regulations into business impact and the implementation of respective legislation
  • 2+ years experience in quality control or manufacturing
  • Ability to quickly and efficiently become familiar with laws and their implementation (focus: chemical regulations)
  • Strong written and oral communication skills
  • Exposure to one or more of the following regulatory agency/services:
    • California Hazardous Material Inventory (CERS)
    • Harmonized System Codes (HS Codes)
    • DOT Hazmat
    • NSF/ANSI 60
  • Ability to work independently with minimum supervision.
  • Effective project management and problem-solving skills.
  • Strong organizational skills and attention to detail

 

Preferred Experience:

  • Supervisory/managerial experience
  • Basic understanding of Spanish language
  • Knowledge of: Microsoft Office, including Word and Excel; Filemaker, CRM or other work management software, Chemdox or other GHS, SDS/label software

 

Job Features

Job Category

Research and Development

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