Job Description

Job Description

About this opportunity :

The Quality Assurance Specialist, Manufacturing Quality Assurance is responsible for overseeing manufacturing batches and operational support activities that are on-going daily. This is a first shift position (Fri-Mon) and comes with a 10% shift differential.

Key Responsibilities:

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• Executes daily line clearance and oversees manufacturing activities by utilizing general area QA oversight checklists.
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• Assist with production and QC to provide Good Manufacturing and Laboratory Practices.
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• Understand and execute MQA responsibilities that are defined in SOP.
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• Monitoring manufacturing operations including cleaning by conducting reviews of logbooks.
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• Escalate detected major issues on the floor to MQA and QA management.
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• Review facility cleaning, material transfers and personnel hygiene control.
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• Providing quality oversight to critical building management system (BMS) alarms, preventive maintenance (reactive work orders), and calibration (out of tolerance).
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• 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.
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• Provide Quality oversight and compliance guidance on new building program initiatives.
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• Train, motivate, monitor, and lead quality teams through necessary change.
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Required Skills/Abilities:

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• At least 3 years' experience in a regulated/GMP industry required, with experience in Pharmaceuticals or Biotechnology preferred.
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• Understanding of 21 CFR 210, 21 CFR 211, and ICH Q7 regulations.
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• Ability to work in a fast-paced environment consisting of internal and external team members with minimal oversight.
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• Problem-solving skills with the ability to adapt to changing priorities and timelines.
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• Ability to build positive working partnerships with other department teams.
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• Experienced in the use of electronic systems such as eQMS.
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• Prior experience with clinical and commercial manufacturing is preferred.
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• Requires the ability to gown into clean rooms and wear PPE.
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The annualized salary range for this role is $67,900.00 - $83,100.00

Job Tags

Shift work, Day shift,

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