Englewood Lab, Inc.
Director of Quality Systems - Cosmetics & Skincare
hace 21 días
Paterson
Job DescriptionTitle: Director of Quality Systems Reports to: Head of Quality and Regulatory Department: Quality Assurance Responsibilities: • Conduct non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups., • Trains and supervises document review personnel; batch release personnel, Maintains accurate record of approved, quarantined, rejected products., • Ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, EPA, OSHA, TGA/PICS, ISO 13485:2003)., • Review and release final product and maintain authorized person (AP) status; also reviews release and compliance of bulk and intermediates where applicable., • Conduct audits and inspections; also prepare draft responses to audits and inspections., • Oversee/coordinate drug stability program., • Oversee process validation lifecycle program., • Oversee document control program., • Support Company’s Global Quality Program., • Maintains 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., • Conduct 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 finished products, when applicable., • Perform supplier and vendor audits, as well as, Mock recall and internal audits., • Any additional duties of assignments as directed by the Head of Quality., • Perform Process Validation and Cleaning & Sanitization Validation under the quality systems to ensure compliance., • Maintains 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., • Initiate 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., • Maintains SOP binders and updates such through approved CCs., • Provide support to all sites relative to Company global quality program., • Communicates new and updated SOPs to all employees at EWL. Qualifications: • Minimum of bachelor degree (Life Sciences, Engrg, related profession)., • Five+ years industry or related combined experience in cosmetic, food, device or pharma., • Previous inspecting, auditing or manufacturing experience - a plus., • Data analysis, specification development skills., • Technical writing ability is essential., • Computer literate and effective communication skills., • Pay range: $130,000 - $150,000 per year, • Medical, Dental, and Vision Insurance, • Life Insurance, • 401k match, • PTO Powered by JazzHR YhbX4CWAte