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Quality Assurance Supervisor - Cosmetics & Skincare

Quality Assurance Supervisor - Cosmetics & Skincare

Englewood Lab, Inc.Totowa, NJ, US
30+ days ago
Job type
  • Full-time
  • Quick Apply
Job description

Title :

  • Quality Assurance (QA) Supervisor  Reports to :  Quality Manager or Head of Quality  Department : Quality Assurance  Responsibilities :   Oversee Quality Systems Modules for compliance (Change Controls, Deviations, Discrepant Materials, Returns, Supplier Issues, etc.
  • Support Investigations (e.g. non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups).
  • Train and supervise document control / review personnel; batch release personnel, accurate record of approved, quarantined, rejected products.
  • Lead the review, release and compliance of materials, FG, bulk and intermediates where applicable, to support customer requirements.
  • Support audits, inspections and ensure compliance to all SOPs and other regulatory requirements (e.g.

FDA, HC, EPA, OSHA, ISO 13485 :

  • 2016).
  • Familiar with US FDA OTC drug regulations, including data integrity requirements.
  • Maintains a working knowledge of QA inspection requirements for components, raw materials, in-process / bulk and finished goods.
  • Ensures that review of in-process activities in both Manufacturing and Warehouse areas is conducted by QA inspectors for conformance to specifications; follow up on out-of-specifications including non conformances.
  • Participates in In-process Quality in-house and outside training program.
  • Conducts periodic analysis of In-process Inspection program for pre-weigh and bulk manufacture and makes recommendations.
  • Assist in interpreting and / or developing of customer specifications and requirements for approved formulas.  Assists in establishing production and assembly inspection information sheets and documentation as required.
  • Maintains and updates ERP System, maintains repository of batch records / documents, and other Mfg & Assembly in-process Specifications.
  • Reviews of batch records, work sheets, and Inspection documentation for completeness and correctness.
  • Support non-conformance resolutions, complaint investigations, and associated corrective and preventative actions.
  • Reviews of QA Inspection reports daily for correctness and completeness.
  • Facilitates on site customer inspections, coordinating availability of product and communication of disposition to Quality and Inventory Control.
  • Interfaces with customer distribution operations where needed.
  • Maintains awareness and compliance with safety regulations in performing job duties.
  • Ensure that finished goods, bulk, raw materials, components are maintained correctly in the warehouse and other holding areas.
  • Assist in the review and release of bulk and finished products, when applicable.
  • Perform supplier and vendor audits, as well as, Mock recall and internal audits.
  • Support Process Validation and Cleaning & Sanitization Validation activities under the quality systems to ensure compliance.
  • Support formal drug stability program, bulk hold studies, and product compatibility by co-ordinating samples submission, testing, result retrieval and program review.
  • Maintains files and database of customer-approvals and documents as evidence of authenticity.
  • Effects changes to specification sheets as approved through proper change control requests.
  • Support Change Control Requests for Customer requested changes to raw material, intermediate / bulk, FGs, specifications.
  • Maintains copies of approved change controls as applicable to product specification updates / revisions.
  • Under the supervision of Quality Manager, review and approved formulas, specifications and procedures.
  • Communicates new and updated SOPs to all employees at EWL.
  • Qualifications :

  • Minimum of associate degree or bachelor degree (Life Sciences, Engrg, related profession).
  • Three + years industry or related experience in cosmetic, device, food, or pharma.
  • Experience / Knowledge of US FDA OTC regulations - a plus.
  • Previous inspecting, auditing or manufacturing experience - a plus.
  • Data analysis, specification development skills.
  • Computer literate and effective communication skills.  Ability to lift and carry up to 10-15 pounds.
  • Compensation & Benefits :

  • Pay range : $60,000 - $65,000 per year  Medical, Dental, and Vision Insurance Life Insurance 401k match PTO Powered by JazzHR
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