Overview
Quality Assurance/QA Lead- Documentation and Product Release Quality Jobs in Totowa, New Jersey, USA at Englewood Lab
Position: Quality Assurance (QA) Lead- Documentation and Product Release – (Quality)
Title:
Quality Assurance
(QA) Lead
– Documentation and Product Release
Reports to:
Quality Assurance
Supervisor or Manager
Department:
Quality Assurance
Responsibilities:
Support Annual Drug and Device History Reviews.
Oversee and maintain the Quality modules in the ERP system for compliance (Change Controls, Deviations, Discrepant Materials, Returns, Supplier Issues, etc.
Support Investigations (e.g. non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups).
Lead the review, release of compliance materials (eg FG, RM, bulk and intermediates as required to support customer requirements). Also maintain accurate record of approved, quarantined, rejected materials and products.
Support audits, inspections and ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, EPA, TGA, OSHA, MFDS, ISO 22716; ISO 13485:2016).
Maintains a working knowledge of QA inspection requirements for components, raw materials, in-process/bulk and finished goods.
Participates in In-process Quality in-house and outside training program.
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.
Support 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 bulk and finished products.
Support Process Validation and Cleaning & Sanitization Validation activities under the quality systems to ensure compliance.
Support 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.
Support 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.
Requirements
Minimum of associate degree or bachelor degree (Life Sciences, Engrg, related profession).
Three + years industry or related experience in cosmetic, device, food, or pharma.
Previous inspecting, auditing or manufacturing experience – a plus.
Data analysis, specification development skills.
Computer literate and effective communication skills.
Benefits
Medical, Dental, and Vision Insurance
Life Insurance
401k match
Title: Quality Assurance/QA Lead- Documentation and Product Release Quality
Company: Englewood Lab
Location: Totowa, New Jersey, USA
Category: Quality Assurance – QA/QC (Quality Control / Manager, Quality Technician/ Inspector, QA Specialist / Manager, Quality Engineering)
