What are the responsibilities and job description for the Quality Control Supervisor (Quality) position at Englewood Lab, Inc?
Title: Quality Control Supervisor
Reports to: QC Manager or Director of Quality
Department: Quality Control
Responsibilities:
- Scheduling of QC Inspectors to one of the following areas: (i) Bulk Mfg with Review of In-process Batch Records and related documentation and Special Sample handling, OR (ii) Production areas/Assembly lines, Warehouse FG auditing, Special Sample handling, Review of In-process Fill/Assembly Records and related documentation.
- Conduct non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups within specified area(s).
- Trains and supervises document review personnel; batch release personnel, issues certificates of conformance (COC), certificates of manufacture (COM), and certificates of analysis (COA) to customers on finished goods. Maintains accurate record of approved, quarantined, rejected products within specified area(s).
- Ensure compliance to all SOPs and other regulatory requirements (e.g. FDA, EPA, OSHA, ISO 13485:2003).
- Reviews finished goods with shipping department for formal FGs release and compliance to customer requirements.
- Work closely with Quality Assurance/Quality Systems Dept on all aspects of Quality and Compliance.
- Maintains a working knowledge of QC inspection requirements for components, raw materials, in-process/bulk and finished goods.
- Ensures that review of in-process activities in Manufacturing or Production/Assembly areas is conducted by QC 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 and makes recommendations.
- Assist in interpreting and/or developing of customer specifications and requirements for assembly/packaging specifications.
- 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 QC 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.
- Reviews Production and in-process related information on batch records/documents.
- 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.
- Perform supplier and vendor audits, as well as, Mock recall and internal audits
- Any additional duties of assignments as directed by the Supervisor.
- Minimum of Diploma or Bachelor degree (Life Sciences, Engineering, 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.
- Computer literate and effective communication skills.
- Medical, Dental, and Vision Insurance
- Life Insurance
- 401k match
