Quality Engineer
Requisition Number:
44801
Corning is one of the world s leading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise in specialty glass, ceramics, and optical physics to develop products that have created new industries and transformed people s lives.
Corning succeeds through sustained investment in R&D, a unique combination of material and process innovation, and close collaboration with customers to solve tough technology challenges.
As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning s Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries.
Scope of Position:
In this role, you will be working with the Quality Assurance & Regulatory Affairs Manager. You will develop and supports all Quality Assurance activities and functions supporting the quality goals and quality metrics for Mediatech Inc. dba Vacca Biologics. The site processes bovine serum for biological and medical applications. You will be responsible for updating SOPs, conducting training on SOPs and general administration and documentation of the Quality System. We also look for you to assure compliance to in-house and/or external specifications and standards such as Good Manufacturing Practices, 21 CFR 820, ISO 13485 and Quality System Procedures.
Day to Day
Responsibilities:
- Direct and support employee training, SOP creation and continual process improvement objectives
- Reviews batch records and performs product release activities.
- Coordinates QC testing including sample submission and testing of hemoglobin via spectrophotometer
- Manage calibration program and record keeping
- Coordinates and leads Quality Documentation, Nonconformance Reports, Inspection Activities, and Product Disposition.
- Coordinates the review and revision of procedures, specifications and forms to maintain and improve the QMS.
- Collaborates with USDA on regulatory compliance activities including regulatory approvals.
- Performs investigations and analysis activities to support resolution of quality issues.
- Collaborates with organizational teams to support quality system implementation.
- Ensures quality standards by following company & departmental policies & procedures including, but not limited to:
- Product performance & quality verification.
- Identifying, recording and investigating problems related to product, process & quality systems.
- Evaluating processes for improvements and standardization.
- Initiating action to prevent non-conformance in products, process and quality systems.
- Training on quality systems as identified by supervisor and required by position.
- Tracking/trending aspects of the QMS.
- Other job duties as required, may need to assist with production activities.
Travel Requirements:
- Less than 10%.
Hours of work/work schedule/flex-time:
- Standard business hours; Monday Friday.
- Some Saturday work as needed.
Required Education:
- Bachelor s degree in Science, Engineering, Bioengineering or related field.
- Prefer Chemistry or Biology degree programs.
Required Years and Area of
Experience:
- 0 1
years experience in Quality or Regulatory role. - Prefer experience in in a medical device, pharmaceutical or biotechnology environment/industry.
Required Skills:
- Must be comfortable seeing and working around blood and unpleasant smells.
- Ability to develop, update and train on SOPs.
- Problem solving techniques to perform investigations and drive root cause analysis.
- Ability to monitor the QMS such as:
Change Control, CAPA, Complaints, Nonconforming Materials and Products. - Batch record review and product release activities.
- Proficient with Microsoft Office software; Word, Excel, Powerpoint, etc.
Desired Experience / Qualifications / Skills:
- SAP, EtQ and/or PeopleSoft experience.
- Experience with statistical analysis.
Soft Skills:
- Adhere to strict safety guidelines and OSHA standards.
- Ability to multi-task with ability to be organized.
- Strong interpersonal and communication skills.
- Strong time management skills and attention to detail.
- Ability to influence others in a team environment while collaborating with peers and functional areas.
- Ability to work independently with minimal supervision.
This position does not support immigration sponsorship.
We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, or veteran status or any other legally protected status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Estimated Salary: $20 to $28 per hour based on qualifications.
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