Quality Associate

Location: Indianapolis, IN
Department: Azzur Chicago, LLC

Job Description

The Quality Associate contributes to meeting company goals of exceptional Client service, quality, process improvement, and profitability by performing the following tasks:
• ensuring accurate shipping and receiving by performing QC checks on all incoming and outgoing materials;
• uploading Temperature Recording Device (TRD) data and handling TRDs according to procedure;
• ensuring compliance with regulatory standards by performing audits according to the audit schedule;
• ensuring accurate inventory management by reviewing and approving all material adjustments (including disposition changes);
• initiating and overseeing quality records within the QT9 electronic QMS, including but not limited to, Deviations, Nonconforming Products, Corrective Actions, Preventive Actions, Audits, Change Control, Risk Assessments, Supplier Evaluation and Qualification and Customer Feedback;
• monitoring CAPAs for effectiveness;
• ensuring all staff have completed properly documented training in QT9, and maintaining employee files;
• assisting the Quality Manager with formal inspection/audit responses;
• assisting the Quality Manager with facility license applications and renewals;
• gathering and trending quality data;
• ensuring proper Client communication as it relates to Quality issues according to the SOPs and/or the Client Quality Agreement.

The Quality Associate is expected to:
• Work according to company policies and procedures;
• Meet established quality and productivity metrics;
• Keep work areas neat and clean;
• Accept or reject material based on quality/regulatory standards and Client requirements;
• Physically check all incoming and outgoing materials for damage and other discrepancies;
• Identify and report discrepancies between paperwork/orders and physical product delivered;
• Initiate and oversee quality records in QT9;
• Provide courteous, professional service to both internal and external Clients;
• Present a positive image Langham.

Critical skills:
• Communication – ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner.
• Analytical Skills – ability to thoughtfully analyze a wide variety of information and data to make key decisions regarding potential risks associated with product quality or regulatory violations.
• Teamwork – ability to establish professional relationships and rapport with internal and external peers and management.
• Proactiveness – ability to anticipate potential problems and risks related to commercial product operations, investigate solutions, and implement preventive actions.
• Organization – ability to manage multiple quality records with various due dates to ensure timely completion and maintain records in a readily retrievable format.

About Azzur

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.

Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

Apply Now

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