QA Specialist II Manufacturing Quality Assurance 8046
QA Specialist II Manufacturing Quality Assurance 8046
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 afirst shift position (MonFri).
Key Responsibilities:
- Executes daily line clearance and oversees manufacturing activities by utilizing general area QA oversight checklists.
- Assist with production and QC to provide Good Manufacturing and Laboratory Practices.
- Understand and execute MQA responsibilities that are defined in SOP.
- Monitoring manufacturing operations including cleaning by conducting reviews of logbooks.
- Escalate detected major issues on the floor to MQA and QA management.
- Review facility cleaning material transfers and personnel hygiene control
- Providing 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 identify propose and lead continuous improvement projects.
- Provide Quality oversight and compliance guidance on new building program initiatives.
- Train motivate monitor and lead 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 fastpaced environment consisting of internal and external team members with minimal oversight.
- Problemsolving 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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
