Overview
Quality Specialist II Jobs in Youngstown, OH at Mitsubishi Electric Power Products, Inc.
Lead the QA/QC Team, monitor documents and activities supporting the quality systems at UDS and its contract manufacturers/packagers where applicable.
These include: SOPs, Forms, Master Batch Records, Batch Records, Change Controls, Non-Conformance Reports, Recall Reports, Complaints, Audits, Supplier Qualification Documentation and Training Documentation.
Unit Dose Solutions (UDS) is a leader in Contract, Hospital and Physician packaging. We are looking for a Quality Assurance Team Lead to work directly with the manager to coordinate compliance / quality assurance activities within our highly regulated industry to ensure that UDS objectives are achieved in compliance with federal, state and company requirements. Be physically present at the establishment during normal business hours.
Required to initiate reports and documents (i.e., Adverse Event Investigations, complaint responses, Field Alerts, Recalls, etc.) that may be submitted to regulatory bodies.
Oversee the inspection of incoming and outgoing finished goods.
Assist with product complaint process, quality document retention, stability program, oversee warehouse environmental monitoring (i.e., temperature mapping/monitoring, pest control program).
Review/approval of manufacturers master batch records, labels, and component specifications.
Provide annual GMP training for local employees, ensure adequate training for self and direct reports.
Oversee Calibration and Validation Activities.
Assist with Training Program.
Review SOPs, Forms, etc. to ensure UDS is within compliance of regulatory authorities.
Track and Trend data for Continued Process Improvement
Minimum Requirements:
Prior pharmacy / FDA / DEA experience
BS in any biological science or comparable experience
Prior experience in cGMP
3+ years of experience in a manufacturing organization
Prior supervisory experience preferred
Ability to read and understand contracts
Salary range is commensurate with experience. Drug test and criminal background check are required for employment.
Job Type: Full-time
Pay: $45,000.00 – $52,000.00 per year
Benefits:
Dental insurance
Health insurance
Life insurance
Paid time off
Tuition reimbursement
Vision insurance
Schedule:
8 hour shift
Work Location: In person
Title: Quality Specialist II
Company: Mitsubishi Electric Power Products, Inc.
Location: Youngstown, OH
