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Assoc Quality Engineer

Iatric Manufacturing Solutions LLC

This is a Full-time position in Jefferson City, TN posted June 4, 2021.

Are you ready for a challenge?   If so, this opportunity may be for you! 

Iatric is seeking an Associate Quality Engineer who will be responsible for the review and maintenance of GMP records and will also provide input regarding specifications, sampling plans, test methods, validation protocols and acceptance criteria for Iatric products.

Iatric Manufacturing Solutions, a wholly owned subsidiary of Rockline Industries, is dedicated to helping foster healthy environments through the design and manufacturing of FDA-regulated wipes for use in the consumer, health care, food service, and hospitality industries. Iatric will operate out of a new 435,000-square-foot state-of-the-art FDA-registered facility in Morristown, TN. The wholly owned subsidiary was born out of the rapidly increasing demand for Rockline’s innovative wet wipes products that are designed to support healthier, sanitary environments and personal hygiene. 

ESSENTIAL ACCOUNTABILITIES:

  • Works with external manufacturers to resolve GMP issues, including follow through on investigations and CAPAs
  • Collects and inputs product testing data for analysis and trending.   Analyzes data (complaints, material nonconformance, and waste) for trends and product quality continual improvement opportunities.
  • Assists in the writing and development of test plans and process/cleaning validation protocols and processes. Provides input for sampling plans, test methods, and acceptance criteria.
  • Assists in the development of technical specifications for materials, intermediates and finished product
  • Leads or assists in the development of QE projects that will assure product safety.
  • Ensures that all work is performed in a safe manner.
  • Assists in the audit process
  • Contributes to a cooperative working effort by demonstrating a willingness to perform other job-related work, as needed or requested. 

 

QUALIFICATION REQUIREMENTS: (To perform this job successfully, an individual must be able to perform each of the essential accountabilities satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.)

  • Bachelors of Science Degree in Engineering, Biology, Chemistry, BioChemistry or a related science required.
  • Previous hands-on Quality Assurance /Quality Control experience, preferred.
  • Excellent analytical and communication skills.
  • Computer proficiency, in Microsoft Excel, Word, and statistical software.
  • Willingness to pursue ASQ technical certification as a CQA and/or CQE.
  • Training in GMPs and FDA regulations, preferred.
  • Prior experience desired in an FDA cGMP manufacturing industry.

 

Experience

Preferred

  • Experience with GMPs in an FDA-regulated environment
  • Quality Assurance, Quality Control

Education

Required

  • Bachelors or better in Engineering or related field

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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