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BD (Becton, Dickinson and Company) Quality Scientist - Chemist in Broken Bow, Nebraska

Job Description Summary

Job Description

JOB SUMMARY

This position is responsible for providing support to the Chemistry Lab relating to the operation and maintenance of analytical testing equipment as it relates to inspections of components and finished goods.

Responsible for overseeing and completing project/validation work as assigned, including but not limited to development and implementation of new product line components or test equipment, or continued product support through routine monitoring. Work to include product development testing, validation of new equipment, and maintenance of processes once released to production.

Prepares and maintains adequate inventory of additive components used for project work. The additives are prepared and assayed according to the appropriate specifications.

Prepares and assists with additional project work and equipment maintenance as necessary, including associated paperwork and/or documentation.

Provides the technical expertise to plan and implement assigned projects, and install and qualify new processes within the chemistry department in support of project objectives.

Develops processes and executes validations, including equipment validations, software validations, and method validations.

Performs procedure validation and training according to Good Manufacturing Practices (GMP) and Corporate Quality Assurance.

Ability to operate all equipment / perform all testing in the lab associated with project and perform basic troubleshooting.

Prepares additives on a routine basis to be used during process development and small-scale production.

Develops a high degree of accuracy and good technique in all laboratory procedures, including additive preparation, chemical assays, preparation of test solutions, mathematical calculations, and maintaining records and log books.

Follows safe laboratory procedures and precautions when operating equipment and handling chemicals.

Provide traceability of materials used during process development and production activities.

OTHER RESPONSIBILITIES

Other responsibilities of this position include but are not limited to:

Complies with, and responsible for enforcing, all local, state, federal and BD safety regulations, policies/procedures.

Complies with all local BD quality policies/procedures/practices through consistent application of sound Quality Assurance principles. Ensures compliance through appropriate communication, training, and education of sound Quality Assurance principles. Responsible for the activities and programs as defined for this position in the Quality Systems Manual - BD Broken Bow.

Performs other job related duties as assigned.

Observes all safety, environmental and quality system standards.

All requirements are subject to possible modification to reasonably accommodate individuals with disabilities.

Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.

This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by their Facilitator.

Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the incumbent will possess the abilities or aptitudes to perform each duty proficiently.

This document does not create an employment contract, implied or otherwise, other than an "at will" employment relationship.

EDUCATION, EXPERIENCE AND SKILLS REQUIRED

B.S. or B.A. Degree in Chemistry, Chemical Engineering, or science or engineering related equivalent. Experience working in a lab preferred.

Working knowledge of validations (IQ/OQ/PQ), DOE’s, and descriptive statistics is highly desirable.

Knowledge of Medical Device Good Manufacturing Practices (GMP, 21 CFR 820) and Good Laboratory Practices (GLP, 21 CFR 58) is desirable.

A minimum of 1 year proven chemistry laboratory experience (or equivalent) is required.

Knowledge of laboratory instruments such as auto-titration systems, blood coagulation analyzers, HPLC, and ICP-MS is highly desirable.

Strong verbal, written, analytical, persuasion and interpersonal skills. Working knowledge of computers. Organizational skills required. Ability to accept responsibility and perform duties with little or no direct supervision.

Ability to manually operate a computer with a standard keyboard, as well as laboratory equipment associated with mixing and testing of additives and applicable product.

This position does not currently supervise others.

Primary Work LocationUSA NE - Broken Bow

Additional Locations

Work Shift

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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