What are the responsibilities and job description for the Quality Assurance (QA) Lead- Documentation and Product Release - (Quality) position at Englewood Lab?
Title: Quality Assurance (QA) Lead- Documentation and Product Release
Reports to: Quality Assurance Supervisor or Manager
Department: Quality Assurance
Responsibilities:
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
- 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
- Medical, Dental, and Vision Insurance
- Life Insurance
- 401k match
