|Fort Worth, Texas - United States
$80,000.00 - $85,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
Will supervise the quality assurance program for the pharmaceutical department of the plant in compliance with federal regualtions, customer expectations and company standards. Will supervise audits and oversee validations of new produts. Large company with lots of growth opportunities throughout the US!
- Analyzes quality control test results and provides feedback to improve quality and operating systems which meet customer requirements and best practice audits
- Supervises inspection of incoming materials, work-in-process materials, rework materials and finished goods to assure the required level of quality through visual inspection, statistical sampling and laboratory testing of materials; ascertains reasons for nonconforming materials Establishes, monitors and controls Hold For Inspection (HFI) procedures to ensure nonconforming materials do not enter the production process and are properly identified and segregated.
- Leads corrective actions for quality related problems at the plant and/or customer location and for start-up of new products
- Utilizes quality techniques to reduce process variations or refine process parameters
- Establishes, monitors, and maintains statistical process control (SPC) programs Leads and promotes problem solving teams to perform root cause analysis and failure investigations
- Implements and tracks corrective and preventative actions to ensure items are successfully closed out on a timely basis
- Alerts management of potential quality problems to assure that defective raw materials are not used or that defective products are not shipped to the customer; ensures that potential defective product is contained and performs necessary sorts
- Assists in development of standard operating procedures, work instructions and form control documents
- Assists with customer complaint investigations and vendor incident notifications
- Supervises audits including internal (i.e., IA, Good Manufacturing Practices), external and customer. Maintains pharmaceutical safety and compliance documentation in accordance with regulatory, customer, and third party audit requirements.
- Visits customers and vendors as needed
- Manages team of direct reports and is responsible for employee selection, development, mentoring, and performance management.
- Education: Bachelor's Degree in Quality, Engineering or a related technical field
- 5 years of experience in a quality assurance role
- Accreditation in Quality (ASQ, CQE) highly preferred
- Strong statistical analysis expertise and experience using SPC
- Experience with internal, customer, and third party Quality System Auditing (FDA QSIT preferred)
- Experience with ISO 13485 quality systems or food safety certifications AIB
- Experience in Medical Device/Pharmaceutical/ or Quality Assurance of aseptic manufacturing preferred
- Experience working in FDA regulated industry preferred (21 CFR 820, Title 21 Part 210-211)
- Experience with automated quality gauging and measurement systems (e.g. AVID)
- Experience with customer relations – written responses, verbal communications and face to face interactions
- Proficiency in the following software: Word, Power Point, Excel, MS Project, Visio
University - Bachelor's Degree/3-4 Year Degree