Manager, Quality Operations

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2nd shift: Summary of Objectives:Responsible for managing 2nd and 3rd shift daily operations of the IQA Receiving and Quality Operations Departments through the activities of the Supervisors, Leads, Auditors, and Inspectors. Responsible for the quality issues/events that occur on 2nd and 3rd shifts.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Provide knowledge, training, leadership, motivation, and guidance to ensure staff have a clear understanding of tasks, responsibilities, business goals, and customer demands.
• Provide 24-hour support for Quality related issues either by phone or email.

• Be observant of processes, performance, and behaviors, focusing on continuous improvement.
• Manage budgets and plans for business growth.
• Compile, analyze, and report key departmental Quality metrics (Product HOLDs, Line Clearance Observations/Failures, Missed events, and Right First-Time metrics).
• Provide support via emails, phone, Quarterly Business reviews/meetings, tours, audits, and investigations.
• Facilitate Annual Product Reviews. Deliver customer satisfaction.
• Perform and participate in tours of functional areas for internal, customer, and regulatory audits. Identify risks, observations, and controls. Communicate results and develop action plans to resolve issues.
• Provide training and presentations to all associates as needed.
• Ensure headcount, staff, and production demands are met.
• Ensure Quality issues are resolved appropriately and report results to Quality and Production Management.
• Responsible for developing, reviewing, and approving department Change Controls for Standard Operating Procedures, Job Aids, Batch Records, Material Specifications, and Forms.
• Responsible for facilitating troubleshooting issues for the department’s testing equipment and or working with vendors to resolve errors.
• Collaborate with Project Management for New Product Development; ensuring batch record documentation and product launches are successful.
• Oversee incoming, in-process, and finished goods inspections of products to ensure conformance to established standards.

• Investigate root causes of quality events/defects and recommend solutions.

• Oversee functions of Incoming Quality Inspection and Quality Operations.
• Manage non-conforming products, materials, and reports (NMRs, Product HOLDs, Line Clearance Failures).

• Manage Batch Record Right First-Time program.

• Ensure compliance for onboarding and training new Quality team members.
• Ability to partner and collaborate with functional departments.

• Order and or approve supply requisitions.
• Oversee Pest Control Program.
• Oversee Mean Kinetic Temperature and Environmental Monitoring.
• Primary Quality Contact for Business Units regarding operational issues.
• Oversee retention of PCI, customer retain samples (retain cage), and outbound retain shipments.
• Provide hands-on training ensuring employees are trained in quality functions. 
• Prepare periodic and special reports concerning departmental activities, problems, quality systems, schedules, etc.
• Lead and drive improvement/harmonization initiatives across multiple facilities.
• Ensure Performance Metrics (Safety/Quality/Regulatory/Delivery), goals, and objectives are on track for completion.
• Report and escalate to Senior Management of any potential risks that impact Quality.
• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.
• Attendance to work is an essential function of this position.
• Performs other duties as assigned by Manager

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Required:

• Bachelor's Degree in a related field and/or 1-5 years of related experience and/or training.

• College Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and knowledge of variou