QA/Regulatory Associate

Candidates with strong background in one area, please apply; training will be provided in to ensure competency in the area of limited experience. 

Position Sumamry: 

To support the activities and responsibilities of the Regulatory function and the Quality Assurance Department.

QA Responsibilities: 

  • Daily review and release of Manufacturing Production Control Records (MPCRs)
  • Prepares Checklist for and Performs Internal Audits and perform follow-ups
  • Creates API and cosmetics work orders when and as needed.
  • Makes and manages necessary changes to existing MPCRs Routings and BOMs
  • Creates Reprocessing Control Work Order Records
  • Prepares QA Annual Drug Product Review and coordinates with QC’s review.
  • Updates QA tracking database timely with quality summaries to support Quality Metrics’ Monthly
  • Maintains database of Suppliers’ Approval Program and responsible for mailing and follow up of supplier questionnaires.
  • Investigates or supports investigations on customer complaints, deviations, and out- of-specification issues.
  • Ability to be cross trained in document control activities and perform duties that become necessary to maintain GMP compliance.
  • Other duties as assigned

Regulatory Responsibilities: Document and manage RSPO materials, API products, and complete associated annual renewal/filings/permits, including FDA Filings

  • Certify all material imports for TSCA compliance and provide updated HTS and FDA codes for import tax and duties
  • Create and maintain information databases for assurance of regulatory compliance and customer requests
  • Maintain archive for resale products (SDSs, TDSs, RMIs)
  • Complete annual renewal of APHIS (lecithin material) import permit
  • Maintain up-to-date regulatory affairs knowledge
  • Other duties as assigned

Qualifications:

  • Bachelor’s Degree preferred, equivalent work experience acceptable
  • Previous experience in GMP manufacturing facility; with 2-3 years’ experience in a regulatory or quality setting.
  • Practical experience and knowledge in Cosmetics and/or Drugs regulations
  • Knowledge of CFR Title 21, FDA and GMP policies and procedures.
  • ASQ Certification preferred or equivalent in auditing or working knowledge of auditing principles.
  • Prior experience creating and maintaining SDSs, a plus
  • Microsoft proficient with working knowledge of Word, Excel, PowerPoint, Access, Adobe Acrobat, and an MRP system (e.g. Sage, SAP).
  • Highly organized; able to manage multiple projects simultaneously.
  • Ability to learn and retain information.
  • Keen attention to detail and strong analytical skills.
  • Excellent written and verbal communication skills; able to effectively manage high volume of email communication.
  • Ability to work with employees at all levels of the organization as well as external parties such as customers and suppliers; service-minded.

 

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Markets Served
Color Cosmetics
Skin Care
Speciality Literature
Formulary
Photocatalytic TIO2 & ZnO