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.