Sr. Manager Quality Assurance - Englewood Lab, Inc

• 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, 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.
• 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.
• Communicates new and updated SOPs to all employees at EWL.

Requirements

• Minimum of associate degree or bachelor degree (Life Sciences, Engrg, related profession).
• Five+ years industry or related experience in cosmetic, device, food, 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.

Benefits

• Medical, Dental, and Vision Insurance
• Life Insurance
• 401k match