What are the responsibilities and job description for the Senior Quality Assurance Specialist - Operations position at Werfen?
If you’re a QA expert when it comes to manufacturing, Immucor has an exciting opportunity for you! We are looking to hire a Sr. Quality Assurance Specialist with a background in blood banking, medical device, and/or the pharmaceutical industry. This critical role is responsible for providing quality oversight at the shop floor level to address immediate quality issues. If you’ve got the necessary skills and experience to excel in this role, we want to hear from you!
This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time .
Sr. Quality Assurance Specialist (Quality / Lean Manufacturing)
Responsibilities
Key Accountabilities
Minimum Knowledge & Experience required for the position:
This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time .
Sr. Quality Assurance Specialist (Quality / Lean Manufacturing)
Responsibilities
Key Accountabilities
- Working with manufacturing operations to solve in-house quality concerns as well as reviewing nonconforming product and recommending disposition
- Working with employees to identify and develop continuous improvement strategies that will drive operational excellence and increased capacity and cost reductions
- Conducting assessments of manufacturing operations to provide focused quality improvement opportunities
- Collecting, sorting and reporting data on operations quality performance metrics as well as providing trend analysis of defects occurring at the shop floor
- Devising sampling procedures and designing and developing forms and instructions for recording, evaluating, and reporting data
- Developing and implementing a shop floor self-audit program, including sharing of findings and determination of proper corrective and preventive actions
- Leading cross-functional teams to implement continuous improvements, 5S, standard work, s value stream mapping exercises, and visual standards
- Participating in CAPA Review Board, Change Orders meetings and other critical decision-making meetings as required to define and assess impact at the shop floor
- Managing the Suppliers Quality Agreements Program
- Working with Research & Development in the verification, validation and transfer of Software/Systems and Assay programs
- Assisting Operations with process validation and equipment/facility qualification for implementation into production
- Representing the Sr. Quality Director and Operations Managers in a variety of forums
Minimum Knowledge & Experience required for the position:
- Bachelor’s degree in Life Sciences / Engineering or other science related or technical field, required
- 7-10 years of current experience in Blood Banking, Medical Device, and/or Pharmaceutical industry
- 5 years in QA function with relevant experience executing, developing and/or administrating cGMP quality programs
- Knowledge of cGMP
- Frequent computer/report work, and administration of quality system programs and resources
- Demonstrated problem solving and root cause analysis skills
- ASQ Certified Quality Auditor (CQA) / Certified Quality Engineer (CQE), preferred
- Experience with Trackwise data management system, preferred
