What are the responsibilities and job description for the Quality Assurance (QA) Supervisor position at Englewood Lab?
Title: Quality Assurance (QA) Supervisor
Reports to: Quality Manager or Head of Quality
Department: Quality Assurance
Responsibilities:
Reports to: Quality Manager or Head of Quality
Department: Quality Assurance
Responsibilities:
- Oversee Quality Systems Modules 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).
- Train and supervise document control/review personnel; batch release personnel, accurate record of approved, quarantined, rejected products.
- Lead the review, release and compliance of materials, FG, bulk and intermediates where applicable, to support customer requirements.
- Support audits, inspections and ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, HC, EPA, OSHA, ISO 13485:2016)
- Familiar with US FDA OTC drug regulations, including data integrity requirements
- Maintains a 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
- Assist 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, when applicable.
- Perform supplier and vendor audits, as well as, Mock recall and internal audits
- 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
- Under the supervision of Quality Manager, review and approved formulas, specifications and procedures
- Communicates new and updated SOPs to all employees at EWL.
- Minimum of associate degree or bachelor degree (Life Sciences, Engrg, related profession).
- Three years industry or related experience in cosmetic, device, food, or pharma
- Experience/Knowledge of US FDA OTC regulations - a plus
- 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
