Chemist

Company: Aaren Scientific
Location: Ontario
Posted on: May 3, 2021

Job Description:

Chemist

AAREN Scientific is a medical device manufacturer located in Ontario, CA that produces a full line of high quality intraocular lenses (IOL's). We are a growing medical device manufacturing company looking for experienced, highly motivated individuals to support the growth initiatives and demands.

Aaren Scientific, Inc., is looking for a Chemist. This individual will prepare, organize and execute a series of chemistry driven activities through various stages of processes in order to guarantee fluid production and proper processing of Heparin Manufacturing, Analytical Testing. Assists in the performance of MDR related testing for new and existing product qualifications in accordance with requirements.

Some of the duties include the following:

• Manufacturing of In-house Heparin product - Dissolution & oxidation of Heparin Sodium, Filtration of Oxidized Heparin, Lyophilization of P-Heparin.
• Operates laboratory equipment including HPLC, GC, UV/VIS spectrometry, FTIR, microplate assay reader, refractometer, viscometer, pH meter, etc.
• Organize and Maintain trace-ability for multiple jobs and projects.
• Performs process optimization: Evaluates and improves existing process documents, analytical test methods, etc. When necessary; prepares validation protocols and reports; updates SOPs and forms when necessary. (maintaining state of the art conditions - as needed).
• Perform routine diagnostic testing of process equipment for trend analysis.
• Prepares regulatory level (trending, vigilance, etc.) reviews and documentation.
• Maintains a position of compliance to established processes and procedures.
• Maintains complete legible and accurate records (records of testing and manufacturing)
• Maintain inventories of various process related supplies and orders chemicals when necessary.
• Perform testing of raw materials and finished products; interpret and evaluate test results; perform calculations as needed; assure compliance with applicable laws and regulations.
• Provide general laboratory support; maintain the R&D/Engineering laboratory as a safe cGMP environment.
• Assist in maintaining compliance in accordance with ISO, and applicable Federal/State Standards
• Participate in MRB, NDC and CAPA investigations/activities as required.
• Performs duties in compliance with ISO 13485, EN46001 and GMP requirements.
• Other duties may be assigned

Qualifications

The successful Chemist must be able to perform each essential duty with a high level of accuracy and professionalism.

• Experience with analytical techniques and instruments.
• The eligible Heparin Chemist will have previous experience working in an ISO certified controlled environment.
• Must be able to perform basic algebra and basic statistical analysis of data sets including standard deviation and related calculations. Ability to perform basic calculations related to quantities and chemical concentrations and analytical test result interpretation.
• Will be a self-starter and be able to complete various tests with little to no routine supervision.
• Must be able to work independently, as well as in a group setting.
• Minimum of two-year college experience with laboratory training in a Science degree (Organic Chemistry - preferred).
• Required minimal courses: General and Organic Chemistry.

Benefits:

Our company offers a great benefit package that includes medical, dental, vision, life insurance, 401k with a match. Moreover, we offer our employees the opportunity to work in a challenging new technology and to be a part of a strong and talented team who enable healthcare professionals worldwide to improve the lives of their patients in ophthalmology.

Keywords: Aaren Scientific, Ontario , Chemist, Other , Ontario, California