The picking up of quality control samples from the production area, evaluation of sterility testing for plated and non plated media, control of documents, setting and evaluation of class II AST products, setting up primary stock cultures, cultivation of cryogenic stock cultures and maintaining good general laboratory practices.
· Review and maintain product compliance specifications, documentation control.
· Gain proficiency on all performance benches.
· Documentation of testing results and determining disposition on finished product.
· Maintain consistency for training tasks in Master Control.
· Maintain SOP criteria for inspection/testing.
· Responsible for maintaining department equipment and ordering consumable stock supplies when necessary.
· Exercise GMP compliance in work environment.
· Work well in a high volume fast paced environment.
· Work closely with Quality Assurance department as a quality team.
· Work in conjunction with Customer Service Representatives to achieve on time product releases for standing orders and special products.
· Work with the continuous improvement program within the department.
· Understand and exercise all safety requirements and procedures.
· Assists in maintaining standards in accordance with GMP's/SOP's and ISO regulations.
· Accomplish department goals.
· Support all company policies.
· Performs other duties as assigned.
· Overtime as necessary.
· Possess a high school diploma or equivalent.
· Some laboratory experience in a biological sciences laboratory.
· A minimum combined 1-2 years of experience of in related QC/QA, microbiology laboratory work in a laboratory setting, or an equivalent combination of education and experience is a plus.
· Familiarity with FDA regulations for medical devices.
· Possess the ability to manage many tasks and in an organized fashion.
· Able to communicate effectively with a variety of departments in regard to quality testing parameters.
· Possess intermediate computer skills, preferably with experience in Microsoft word to include Word, Excel and PowerPoint programs. Experience working in SAP is a plus.
· Listen to, and follow, written and verbal instructions.
· Able to adapt and to learn new procedures and to maintain a scientific and objective approach.
· Must maintain a professional work place attitude.
· Self-motivated, highly responsible and possess a good team work spirit.
· Excellent verbal and written skills in English.
Non-Negotiable Hiring Criteria:
· Cannot be color blind; must be able to distinguish different colors.
· Must successfully clear a tuberculosis (TB) screen.