• 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