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Quality Lab Supervisor

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Date: May 9, 2022

Location: Kennebunk, ME, US, 04043

Company: Corning

Requisition Number: 52920

 

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.

Role Purpose

Facilitate and direct daily quality control testing laboratory activities to ensure control and compliance to established laboratory process controls and operating procedures. Achieve department requirements for safety, quality, product release, equipment uptime, sample throughput, and cost. Ensures goods are tested to meet release commitments. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Ensures product, validation and complaints testing is completed in a timely manner to determine and maintain the quality and reliability of products. Supports or leads continuous improvement initiatives for the product release process. Manages the calibration program to ensure all instruments are acceptable for use. Works within department and with outside laboratories on resolution of testing issues in a timely fashion.

Key Responsibilities

• Directly supervise the daily activities and the technical direction of the Quality Control Laboratory personnel and the General QA Inspector/Calibration Administrator.

• Leading the personnel and technical operations of the Quality Control Laboratory. This includes supervising the work of the Laboratory Technicians, prioritizing work, and providing technical expertise when required.

• Encompass the application of scientific and technological principles concerned with the integrity of manufactured products and processes from an engineering standpoint, esp. design specifications, testing procedures, and minimum quality standards.

• Responsible for investigating lab test failures and rejecting product when lab testing indicates that product is defective.

• Managing the transfer of all new techniques from Development and Applications to the Quality Control Laboratory and must understand the underlying principles of these new techniques.

• Scheduling and ensuring that training is completed for all new hires and future temporary or full-time technicians to test products per the established procedures.

• Adapting or developing the test methods used for product evaluations and must successfully transfer these methods over to the person responsible for functional testing.

• Audits quality systems for deficiency identification and correction. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.

• Interface with Engineering, Development, and Applications on the development and maintenance of new products, processes and testing methods.

• Enhance and improve existing products through the development or transfer (from Development or Applications) of new and innovative testing techniques.

• Manage the evaluation of products returned through the complaint system for performance using established and developed testing methods.

• Attends and participates in complaint reviews to review customer complaint information for trends and recommend improvements.

• Participate in customer audits and visits as needed as a technical/quality representative where required.

• Determine and approve specification of laboratory equipment. • Approval Certificate of Compliance templates and Quality plans.

• Manage particulate and microbial environmental monitoring programs and trending, including issuance of CAPAs as appropriate.

• Adherence to safety guidelines by all personnel utilizing the laboratory facilities.

• Manage/Perform the sterility audits and processes

• Preliminary approval of all laboratory purchases.

• Review and approval of cleanroom certificates.

• Participates in New Product/Process projects as well as internal improvements.

• Responsible for identifying, hiring, and managing the performance of all lab personnel.

Experiences/Education Required:

• Minimum of a 4-year degree the field of science including microbiology, chemistry, biology or related science fields

• A minimum of 2 years of QC Laboratory or equivalent work experience.

• Familiarity with ISO 9001, FDA QSR part 820 and/or all required ANSI / AAMI / ISO or USP standards and regulatory requirements.

• Familiarity with cGxP environments and QC testing methodologies (e.g. pH, osmolality, density, endotoxin, sterility, cell culture, and microbiological methods)

• Experience with investigations and root cause analysis.

• Proficiency in Microsoft Word and Excel

• Must be detail-oriented

• Able to work well both independently and in a group setting

• Ability to lead small teams Desired:

• Track record of delivering results

• Understanding of Manufacturing processes

• Demonstrated experience leading team

Travel Requirements: • Less than 10% domestic.

Hours of work/work schedule/flex-time: • Monday – Friday, standard business hours. • Some flexibility may be needed for training and other laboratory activities.

Soft Skills:

• Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product teams.

• Ability to make decisions regarding product disposition.

• Able to give direction to accomplish work you're leading.

• Ability to influence individuals without authority and to motivate others within the laboratory team.

• Action oriented, can make informed decisions, self-motivated, capable of influencing without authority. Collaborative with strong initiative and positive mindset.

• Effective communicator (written and verbal), highly organized, motivated, detail oriented with excellent analytical thinking and problem-solving skills.

• Flexibility to assume ownership on projects and coordinate the efforts of others to complete project goals or participate on a team to support other project Leads; should also be able to effectively handle conflict.

 

Sponsorship is not available for this position.

 

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: Portland Maine