Quality Assurance Compliance Specialist - Cosmetics & Skincare

Totowa, NJ
Full Time
Mid Level
Title: Quality Assurance Compliance Specialist
Reports to: Quality Systems Manager
Department: Quality

Responsibilities: 
  • Lead and conduct investigations into failed materials and systems, including product complaints, non conformity, out of specifications and out of trends, quality incidents reporting.
  • Reviews and approves/confirms all new formulas in the Quality Systems.
  • Assist with creating and revising of Standard Operating Procedures and maintains/updates existing SOPs.
  • Initiates, reviews Non- conformance reports, completes Root Cause Analysis and CAPA.
  • Maintains Change Control Notices (CC) and effects changes to product specifications for raw materials, bulks, intermediates and finished goods.
  • Participates in internal and external audit process.
  • Perform periodic and scheduled audits of Analytical and Micro Lab per Data Integrity requirements.
  • Participates in product recall audits.
  • Maintain investigation records and associated documents.
  • Assist in conducting follow-up to CAPA effectiveness, including close-outs.
  • Using Quality Module within the ERP system, maintain evidence of manufacturing and production investigation to support current GMP processes.
  • Brings discrepancies to the attention of immediate supervisor for resolution.
  • Maintains files of existing specifications for customers and EWL codes.
  • Maintains files and database of customer-approvals and documents as evidence of authenticity.
  • Routinely reviews customer transmittal (through customer portals, emails, or facsimile, etc) of new or updated raw material specifications.
  • Effects changes to specification sheets as approved through proper change control requests.
  • Initiate Change Control Requests for Customer requested changes to raw material, intermediate/bulk, Finish Goods and specifications.
  • Initiate Investigations, complete root cause analysis and drive implementation of adequate/effective CAPA. 
  • Maintains copies of approved change controls as applicable to product specification updates/revisions.
  • Maintains SOP binders and updates such through approved Change Controls.
  • Communicates new and updated SOPs to all employees at EWL.
  • Ensures that product specification updates are implemented in timely manner.

Qualifications:
  • Minimum of 2 years of college.
  • 3 to 5 years industry or related experience.
  • Previous experience in Pharma, Cosmetics, food, medical device, or allied profession. 
  • Good Technical Writing ability.
  • Excellent knowledge of Word, Excel, Access, and other Windows-based programs. 
  • Good record-keeping skills.
  • Ability to lift and carry up to 10 - 15 pounds.
Compensation & Benefits: 

  • The approximate pay range for this position is $65,000 - $75,000. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities. 
    The benefit package includes: 

    • Medical, Dental, and Vision Insurance
    • Life Insurance
    • 401k match
    • PTO 
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