Quality Assurance (QA) Manager - Pharma Not right for you? We've got others

Salary:
Confidential
Location:
Jackson, NJ
Posted:
September 19th 2022
Minimum Degree:
Bachelor of Science
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The Quality Assurance Manager, Manufacturing is responsible for the overall performance of the Manufacturing Quality Assurance team to maintain GMP Compliance, enforce good documentation practices.

• Oversees, manages, coordinates, and prioritizes the daily activities related to Manufacturing QA inspectors such as sampling, inspection, equipment challenges, batch record review, issuance and control of printed material, line clearances, and retain program.
• Ensures cGMP and FDA compliance by all manufacturing employees to best practices, standards and quality.
• Partners with Technical Operations, Engineering, and Validation departments to identify Quality and Compliance risks and develop / implement plans to mitigate via a risk management approach.
• Ensures and enforces departmental compliance of all related facility SOPs and cGMPs.
• Oversee release of Manufacturing Controlled Area, passivation records, conditional releases, cleaning verifications, water releases and Notice of Rejection records.
• Responsible for QA hold, Sample request processes as well as final QA approval manufacturing work orders
• Ensure training is up to date for all team members to remain compliant.
• Review, Assess, and approve deviation reports, change controls, product complaints, product specifications, manufacturing / engineering protocols, SOPs, master batch records and forms.
• Participates in the recruitment process of interviewing and hiring.
• Conducts performance evaluations of direct reports and assists direct report supervisors with the performance evaluation process.
• Lead continuous improvement program for Quality Assurance Operations.
• Collaborate and interact internally and with customers for Root Cause Problem Solving events to address investigations and customer inquiries from a Quality perspective.
• Prepare monthly and/or quarterly quality metric presentations.
• Support client audits and regulatory inspections for QA.
• Utilize investigative techniques to determine root causes of deviations and to determine the proper corrective and preventive actions.
• Responsible for workforce management activities including, but not limited to, interviewing, hiring, training, coaching performance management, discipline, and termination recommendations.
• Develop, motivate, and lead direct reports towards achieving organizational goals.
• Lead Tier 2 Daily meetings and attend Tier 3 daily meetings as the Quality Assurance lead.
• Responsible for scheduling. Facilitates transitions between shifts and seamless handoffs. Communicates key information to peers, team members and production management.

Requirements:

 

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