Overview
Quality Assurance Coordinator Jobs in Saint Petersburg, FL at WESTCARE GULFCOAST-FLORIDA INC
Title: Quality Assurance (QA) Supervisor
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.
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.
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.
Benefits
Medical, Dental, and Vision Insurance
Life Insurance
401k match
Title: Quality Assurance Coordinator
Company: WESTCARE GULFCOAST-FLORIDA INC
Location: Saint Petersburg, FL
