Lead Quality Inspector (APU 3 2nd Shift)

This is a 2nd Shift Position. Working hours are Monday through Friday, 2:00 PM to 10:30 PM.

KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS:

• Assist Operational Quality Manager in coordinating and executing objectives throughout the company in cooperation with other Lead Quality Inspectors to maximize product quality and operating system efficiency/effectiveness to minimize costs.

• Direct and coordinate the activities of Quality Inspectors engaged in the evaluation of goods.

• Perform all the functional duties and responsibilities of the Quality Inspector.

• Plan and establish work schedules for the QC inspectors, assignments, and production sequences to meet production goals.

• Read and analyze charts, work orders and other records and reports, in order to determine resource requirements.

• Review data and documentation for accuracy and correctness and ensure processing is performed within established time expectations.

• Analyze statistical data to determine adequacy of present standards and establish quality plans. This includes analysis of current inspection methods and sample plans.

• Assist in the oversight of nonconforming product during the production stage, managing daily material disposition.

• Responsible for batch release, CoC/ CoA creation

• Ensure all in-process and start-up requirements are met with respect to LRP and usage decision, consult with Operational Quality Manager for discrepancies.

• Responsible for the LRP closure and compliance to company cGMP.

• Prepare necessary quality and safety reports.

• Consult with management and staff to address work related issues/complaints with support of Operational Quality Manager and Quality Engineer.

• Observe work performed by Quality Inspectors to ensure staff conforms to quality system standards.

• Participate in investigations regarding customer complaints.

• Utilize problem solving techniques to reduce internal and external failures.

• Provide training as needed for the QC department.

• Executes specific responsibilities as defined within the company quality system.

• Supports and maintains all policies of the company including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiatives.

• Coach and mentor employees to ensure they maintain or exceed company and/or department performance expectations.

• Provide feedback and performance information to Quality Managers to assist in their preparation of Performance Reviews.

• Other duties as assigned.

POSITION REQUIREMENTS:

• Associates Degree or minimum of 3 years related work experience with one of those years in a leadership role.

• Must be able to perform all quality inspector functional job responsibilities.

• Good working knowledge of raw materials, production processes, costs, and other techniques to maximize effectiveness. · Knowledge of inspection tools, use, and maintenance of those tools required. · Must be self-directed and demonstrate skills in planning and organizing. · Able to lift up to 35 lbs. · Ability to sit, stand, walk 80% of shift required.

PREFERRED KNOWLEDGE/SKILLS:

• Excellent oral and written communication skills.

• Ability to apply basic mathematical concepts.

• General knowledge of PC applications such as Microsoft Word, Excel, and Database software.

WORK ENVIRONMENT:

• Works in a clean room manufacturing environment that may include moderate noise levels and required appropriate cleanroom apparel.

• Ability to travel between office and production departments as well as company buildings required.