Overview
QA Specialist II, Manufacturing Quality Assurance Jobs in Cincinnati, Ohio, USA at Avecia Pharma
QA Specialist II, Manufacturing
Quality Assurance
Mar 13, 2025
Regular Full Time
About this opportunity :
The QA Specialist, Manufacturing Quality Assurance is responsible for overseeing manufacturing batches and operational support activities that are ongoing daily. This is a first shift position (Mon-Fri).
Key Responsibilities:
Executes daily line clearance and oversees manufacturing activities by utilizing general area QA oversight checklists.
Assists with production and QC to provide Good Manufacturing and Laboratory Practices.
Understands and executes MQA responsibilities that are defined in SOP.
Monitors manufacturing operations including cleaning by conducting reviews of logbooks.
Escalates detected major issues on the floor to MQA and QA management.
Reviews facility cleaning, material transfers, and personnel hygiene control.
Provides quality oversight to critical building management system (BMS) alarms, preventive maintenance (reactive work orders), and calibration (out of tolerance).
Based on outcomes of QMRs, quality council, internal and external audit findings, and QA operational (e.g., MQA) findings, identifies, proposes, and leads continuous improvement projects.
Provides Quality oversight and compliance guidance on new building program initiatives.
Trains, motivates, monitors, and leads quality teams through necessary change.
Required Skills/Abilities:
At least 3 years’ experience in a regulated/GMP industry required, with experience in Pharmaceuticals or Biotechnology preferred.
Understanding of 21 CFR 210, 21 CFR 211, and ICH Q7 regulations.
Ability to work in a fast-paced environment consisting of internal and external team members with minimal oversight.
Problem-solving skills with the ability to adapt to changing priorities and timelines.
Ability to build positive working partnerships with other department teams.
Experienced in the use of electronic systems such as eQMS.
Prior experience with clinical and commercial manufacturing is preferred.
Requires the ability to gown into clean rooms and wear PPE.
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Title: QA Specialist II, Manufacturing Quality Assurance
Company: Avecia Pharma
Location: Cincinnati, Ohio, USA
Category: Quality Assurance – QA/QC (QA Specialist / Manager, Quality Control / Manager, Quality Technician/ Inspector, Quality Engineering), Manufacturing / Production (QA Specialist / Manager, Quality Engineering)
