About the Position

The Quality Assurance Lead is responsible for acting as a coach and trainer of Quality Assurance Coordinators. The job coaches and trains teammates to fulfill their individual daily tasks in addition to their own. The Lead may have various responsibilities based on the specific department, this can include, but is not limited to inventory control for quality issues, audits, document control and management. The lead will provide backup to the Quality Manager as needed.

Functions

• Train new Quality Assurance Coordinators:
• Inventory management
• How to perform quality audits
• Document management and control including change management
• Oversee the workflow and assignments of the Quality Assurance Coordinators and provide prioritization
• Conduct audits of the facility for observations for maintaining GMP (General Manufacturing Practice) protocols, process control related to the management of inventory as per customer and company expectations.
• Maintain, update, and add as necessary site policies, procedures, standard work instructions, and tools to improve the efficacy of the quality management system.
• Administer internal audit program to ensure compliance to the quality management system through training auditors, auditing processes and procedures, and measuring results.
• Identify training needs and organize training interventions to meet quality standards.
• Investigate customer complaints and non-conformance issues and perform root cause and corrective action investigations to improve the quality management system.

• Collect and compile statistical quality data and analyze to identify areas for improvement to the quality management system.

• Safely operate powered industrial equipment to move products or materials for distribution such as clamp/slip sheet equipment; load, unload, and store materials/products in designated areas.
• Complete applicable paperwork for inventory
• Participate in inventory/cycle count activities as needed and report variances to leadership.
• Participate in Gemba walks
• Update the daily SQDPCM boards for metrics. Attend daily Tier 3 meeting.
• Ensure facility is inspection ready at all times for SQFI, FDA, and customer needs.
• Communicate and report any incidents to supervisor/manager
• Depending on specific department other duties may apply.

Qualifications

• 2-4 years' experience in a quality assurance role

• Knowledge and experience with ISO 9001:2015

• Lead Auditor Certification preferred

Competencies

• Action Oriented – Taking on new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm.

• Collaborates – Building partnerships and working collaboratively with others to meet shared objectives.

• Decision Quality – Making good and timely decisions that keep the organization moving forward.

• Optimizes Work Processes – Knowing the most effective and efficient processes to get things done, with a focus on continuous improvement.

• Situational Adaptability – Adapting approach and demeanor in real time to match the shifting demands of different situations

Travel Requirements

• This position is expected to travel approximately 25% or less.

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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)