Englewood Lab, Inc.
Quality Assurance Supervisor - Cosmetics & Skincare
14 days ago
Paterson
Job DescriptionTitle: 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 obtLtIxvhl