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Quality Investigation & Improvement Specialist

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Date: Jul 9, 2021

Location: Manassas, VA, US, 20109

Company: Corning

Requisition Number: 45816

 

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 provide technical support of cross-functional goals by utilizing established mathematical/statistical, scientific, and engineering first principles to compile, analyze data, and write technical reports detailing procedures, outcomes, and conclusions. Also provides technical support of improvement implementation initiatives by leading and participating in project teams. We look for you to rely on instructions and pre-established methods to perform assigned tasks, but a certain degree and latitude will be required to resolve problems and make recommendations. Work is performed under general supervision.

 

Day to Day Responsibilities:

  • Develops and maintains a high level of product, analytical, and process knowledge.
  • Participates in process development projects as a technical subject matter expert.
  • Leads and participates in project teams to quickly and effectively implement process improvements directed by root cause analysis to prevent issue recurrence.
  • Participate in Performance Excellence activities to include leading, participating, or coaching project teams, facilitating events, or providing training.
  • Performs customer complaint investigation/resolution and advanced product technical inquiries (e.g. product use, claims, applications).
  • Drives customer issues to resolution to include supporting cross-functional efforts to implement corrective/preventive actions.
  • Investigates the quality of cell culture media and reagents, microbiology media, and molecular biology reagents when issues arise in production (or via external complaints).
  • Supports the authorship and review of product technical literature resources, SOPs, and specifications as assigned.
  • Prepares technical investigation summaries and process/analytical protocols for internal use. Contributes ideas and suggestions to improve standard laboratory techniques, improve protocols, products, processes, and equipment.
  • Functions as a conduit of process and product information from the customer to Mediatech and ensures this customer information reaches the appropriate parties within Mediatech.
  • Aligns the customer’s technical expectations with Mediatech’s capabilities and plans, including specification management and the articulation of a clear business case to justify changes.
  • Identifies gaps in customer needs not met by Mediatech’s current products and works with Account Management, Product Line Management, and Product Development to determine whether Mediatech could and should address these gaps.
  • Identifies opportunities for product enhancements that optimize the customer’s performance based on an intimate understanding of the customer’s product value proposition.

 

Travel Requirements:

  • Negligible

 

Hours of work/work schedule/flex-time:

  • Standard business hours; Monday – Friday.

 

Required Education:

  • Bachelor’s Degree – Engineering, Quality, Life Sciences or related field.

 

Required Years and Area of Experience:

  •  Minimum of 3+ years quality experience.

 

Required Skills:

  • Knowledge/experience in a regulated industry (cGMP, GLP, ISO, etc.)
  • Proficiency with Microsoft Office products (Word, PowerPoint, Excel, Visio).
  • Experienced with investigations using tools like (5Y, 8D, etc.)
  • Demonstrated technical writing skills.
  • Working knowledge of databases and spreadsheet applications to perform necessary tasks for preparing required data analysis, reports, documents and general communication.

 

Desired Experience / Qualifications / Skills:

  • Advanced degree – Life Sciences or related field.
  • Prefer exposure to ISO13485 and 21CFR820.
  • Experience preforming CAPA, SCARS and risk assessments.
  • Advanced proficiency with Microsoft Office products (especially in Visio and Excel).
  • Familiarity/experience with Six-sigma/Lean.
  • Understanding of typical (bio)pharmaceutical industry manufacturing strategies/processes/equipment.
  • Proficiency with Minitab software.
  • ASQ certifications preferred.
  • Exposure to aseptic processing concepts.

 

Soft Skills:

  • Must be detail oriented.
  • Able to work well both independently and in a group setting.
  • Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with project teams.
  • Ability to make decisions regarding product disposition and corrective and preventive action effectiveness.
  • Comfortable in giving direction to accomplish work you're doing.

 

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, 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.


Nearest Major Market: Washington DC