Easter Seals Jobs

Work Schedule

Other

Environmental Conditions

Office

Job Description

Position Objective:

This role supports our Cell Culture Media manufacturing process and is primarily office-based. Essential functions include daily raw material releases, ensuring timely system review and approval and customer communication of raw material changes as well as supporting projects within the Core QA department.

Successful performance of job duties contributes to meeting on time release metrics, Customer Satisfaction and critical metrics.

Essential Functions:

• Ensuring on time daily release of incoming raw materials in the facility

• Responsible for Quality documentation review for new raw materials being introduced, as well as changes to raw components – all carried out in Oracle

• Completion of risk assessments for Raw Materials

• Review of raw material supplier information, critical to the manufacturing operation

• Responsible for communicating, where required, raw material changes to Bioproduction Customers – and management of response/product holds.

• Provide training and work effectively together in team to meet the department goals and critical metrics.

• Participate in customer audits, attend technical visits and fully support and engage in customer calls

• Embrace site PPI initiatives and ensure all team members adopt this methodology

• Participate in personal development to further enhance skills and knowledge relevant to the position

• Maintain working knowledge of Regulatory and Quality System requirements (ISO13485/FDA CFR)

• Utilise the Trackwise system for non-conformances, deviations, Corrective and Preventative Actions (CAPA).

• Perform independently without continual direction and exercise considerable latitude in determining technical objectives and solutions to complex problems. Identify and implement opportunities for improvement across the operational function.

• May be required to carry out other duties as needed

Education:

Bachelors/Masters degree in chemistry, biochemistry, microbiology, engineering or related field preferrable.

Experience:

A minimum of 5 years related quality experience and demonstrated working knowledge of compliance, quality and scientific principles.

Strong oral and written communication skills with a demonstrated ability to work in a cross-functional team environment and to effectively interact with all levels in the company. Effective interpersonal skills and the ability to collaborate with internal and external customers are critical.

Must be a self-starter who can take general concepts and direction and produce desirable results. Also must function effectively and efficiently in a global, multi-site organization

Contacts:

Will collaborate closely with all other departments on matters relating to quality and service in order to uphold the Company’s dedication to Customer satisfaction. This involves working with people at all levels within the organisation as well as external customers and regulatory bodies.

Working Conditions:

Works in an office environment but may be required to spend some time in manufacturing and the warehouse. Must be able to work overtime to complete daily tasks

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.