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Quality Assurance (QA) Manager - Pharma

Company: Job Juncture
Location: Jackson
Posted on: September 22, 2022

Job Description:

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:


  • Bachelor's degree (BA or BS), preferably in a Chemistry, Biology, Pharmacy, Engineering, or other related technical or business administration field.
  • Minimum of 5 years of relevant experience in the pharmaceutical industry for Quality Assurance and Manufacturing environment.
  • 5 years or more of management of people, projects, functional area or a combination is preferred.
  • Excellent written and oral communication skills, sound decision-making based on experience, good supervisory skills including the ability to delegate effectively, good people-skills including the ability to coach and teach subordinates.

Keywords: Job Juncture, Brick , Quality Assurance (QA) Manager - Pharma, Executive , Jackson, New Jersey

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