Quality Specialist

Requisition Number: 63530

Corning is vital to progress – in the industries we help shape and in the world we share.

We invent life-changing technologies using materials science. Our scientific and manufacturing expertise, boundless curiosity, and commitment to purposeful invention place us at the center of the way the world interacts, works, learns, and lives.

Our sustained investment in research, development, and invention means we’re always ready to solve the toughest challenges alongside our customers. 

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 Site Lead.  You will develop and support all Quality Assurance activities and functions supporting the quality goals and quality metrics for Mediatech Inc. dba Vacca Biologics.  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:

        o Product performance & quality verification. o Identifying, recording and investigating problems related to product, process & quality systems.

        o Evaluating processes for improvements and standardization. o Initiating action to prevent non-conformance in products, process and quality systems.

        o Training on quality systems as identified by supervisor and required by position.

        o Tracking/trending aspects of the QMS.

Required Education:  Minimum of Bachelor’s degree in Science, Engineering, Bioengineering or related field; prefer Chemistry or Biology degree programs

Preferred Years and Area of Experience:  0 - 1 years’ experience in Quality or Regulatory, preferably in a medical device, pharmaceutical or biotechnology environment/industry

Travel Requirements:  Less than 10%.

Hours of work/work schedule/flex-time:  Standard business hours, Monday – Friday; some Saturday work as needed

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
• Knowledge of computer programs, such as Word, Excel, Powerpoint, etc.
• Adhere to strict safety guidelines and OSHA standards

Desired Experience / Qualifications / Skills:

• SAP, EtQ and/or PeopleSoft experience
• Experience with statistical analysis

This position does not support immigration sponsorship.  

The range for this position is  $62,764.00   -  $86,301.00 assuming full time status. Starting pay for the successful applicant is dependent on a variety of job-related factors, including but not limited to geographic location, market demands, experience, training, and education. The benefits available for this position are dependent on hours worked and may include medical, dental, vision, 401(k) plan, pension plan, life insurance coverage, disability benefits, and PTO.

Corning Puts YOU First! 

We are committed to supporting your health, financial, career development, and life goals as you grow professionally and personally to achieve your highest potential. All benefits begin as soon as you start your career at Corning. 
 

• Our monetary peer-to-peer recognition program is tied to our Values and celebrates you and your colleagues’ contributions. 
• Health and well-being benefits include medical, dental, vision, paid parental leave, mental health/substance use, fitness, and disease management programs.  
• Financial benefits include a 401(k) savings plan with company matching contributions and a 100% company-paid pension benefit that grows steadily throughout your career. 
• Companywide bonus and attractive short- and long-term compensation programs are available based on your role and responsibilities.   
• Professional development programs help you grow and achieve your career goals.

We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, 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. To request an accommodation, please contact us at accommodations@corning.com.