Quality and Regulatory Specialist

Location
92010, Carlsbad
Posted
Oct 20, 2021
Required Education
Bachelors Degree
Position Type
Full time

Responsibilities:

  • Controls product quality and packaging specifications, process and maintain MFG retains receipts, performs physical inspections, and support in-house production quality compliance assemblies
  • Manage QA data logs, support and reports data accessibility and visibility to QA & Regulatory Manager
  • Process and sort QA performance data regularly, as well as product statistical reports, present and suggest actions to the QA & Regulatory Compliance Manager
  • Responsible for controlling and processing manufacturing production regulatory documents, work with FRT and CMO’s to support data management and organization 
  • Manage, organize and support government licenses documents needed for global import and export
  • Responsible for conducting testing procedures to ensure that products comply with quality standard specifications
  • Prepare, maintain, and report test data for review
  • Communicate quality or compliance concerns to QA & Regulatory Compliance Manager
  • Manage PIF Regulatory folders and artwork IL’s files database
  • Process vendors audits/cGMPs documents, support vendors QA qualifying procedures, and facilitate sites inspections processes  
  • Manage and control customers complaints and Quality RMA’s returns process
  • Partner in the implementation and adjustment processes of quality assurance goals, objectives and procedures
  • Work with HR in support of company quality standards as well as ensuring health & safety issues in compliance with SOPs
  • Support OSHA regulations, and safety training
  • Perform Quality tasks as needed and assigned by QA Manager
  • Travel on occasion to off-site locations for Quality compliance and issues

Requirements

  • 3 or more years of experience in Quality and Regulatory
  • Experience in the Pharmaceutical, Diagnostic, or Health & Beauty industry is preferred
  • BA/BS degree required, or equivalent education and directly related years of experience.
  • Hands on knowledge in quality control and assurance standards practices
  • 3 or more years of experience in cGMP/FDA/ISO and regulated OTC or Rx products
  • Ability to communicate effectively, orally and in writing, with employees and all other internal and external contacts
  • Ability to think strategically and be extremely detail oriented
  • Demonstrated ability to work in a team oriented, collaborative environment
  • Ability to multi-task, prioritize, and manage time effectively.
  • Effective planning, analyzing information and metrics, relationship-building, and strong problem-solving skills
  • Experience working with NetSuite, or other ERP system, order entry portal, or CRM system
  • Advance level in Microsoft PowerPoint, Word, and Excel
  • Ability to work cross-functionally with other departments with the ability to manage upwards and downwards

Physical Requirements:

  • Must be able to remain in a stationary position for long periods of time
  • The person in this position needs to occasionally stoop, bend, and kneel
  • Constantly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer
  • Ability to consistently lift/move inventory in excess of 50 pounds.
  • Must be able to perform the physical tasks required by the position