Director of Quality Systems - Cosmetics & Skincare
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.
- 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.
- Ability to lift and carry up to 10-15 pounds.
- Pay range: $130,000 - $150,000 per year
- Medical, Dental, and Vision Insurance
- Life Insurance
- 401k match
- PTO
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