Director of Quality Systems - Cosmetics & Skincare

Totowa, NJ

Full Time

Senior Manager/Supervisor

Title: 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.
Ability to lift and carry up to 10-15 pounds.

Compensation & Benefits:

Pay range: $130,000 - $150,000 per year
Medical, Dental, and Vision Insurance
Life Insurance
401k match
PTO

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Director of Quality Systems - Cosmetics & Skincare

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