Working hours are Monday through Friday, 10:00 PM and 6:00 AM.
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.