Job Description
Job Description
Quality Assurance
Quality Assurance is a Professional Position. It oversees the numerous quality systems mandated by regulations and monitors for compliance to laws and regulations. The Quality Assurance Position reports to the Vice-President.
Requirements for the Position:
Pass a Drug Test and sign an Employment Agreement containing an Intellectual Property Rights Section
Have an associate's degree in BioScience
Have One or more years 'experience
Complete a Safety Course and a Microbiology Course within 6 months of start date
Qualifications:
Be technically competent in BioScience
Be demanding but realistic in expectations of team members
Demonstrate the ability to grow with the expanding responsibilities of the job
Be steady and determined to reach extraordinary goals
Have experience in Quality Systems
Have knowledge of cGMP, GLP, QMS, ISO, FDA requirements for medical device manufacturing
Have ability to address product/process deviations and complaints
Understands Regulatory and Production constraints inherent to medical device manufacturing
Responsibilities:
Evaluate the accuracy of existing quality assurance measurement techniques
Improve efficacy and reduce errors
Document quantifiable characteristics of finished goods
Complete deviation forms and record findings
Host and assist with all regulatory audits and requests
Release products made at facility
Manage and perform all equipment calibrations
Approve of all raw materials used in the manufacturing processes
Document control and change systems
Maintain a favorable and collaborative environment
Proactively manage multiple projects
Have excellent written and verbal communication skills
Work independently, manage time efficiently, and communicate clearly
Company DescriptionOxyrase, Inc. is an ISO9001:2015 certified biotechnology manufacturing company and for over 30 years we have focused on providing our unique oxygen removal technology to many industries. We make a proprietary product, which is an enzyme system that efficiently and specifically removes oxygen from liquid, semisolid, and indirectly from gaseous environments.
From our facility in north central Ohio, Oxyrase, Inc. manufactures this enzyme system and incorporates it into unique products that optimize its action for a given application. Many of these products are directed to anaerobe microbiology: the science of isolating, growing, and identifying microorganisms which thrive in environments devoid of oxygen.
Company Description
Oxyrase, Inc. is an ISO9001:2015 certified biotechnology manufacturing company and for over 30 years we have focused on providing our unique oxygen removal technology to many industries. We make a proprietary product, which is an enzyme system that efficiently and specifically removes oxygen from liquid, semisolid, and indirectly from gaseous environments.\r\n\r\nFrom our facility in north central Ohio, Oxyrase, Inc. manufactures this enzyme system and incorporates it into unique products that optimize its action for a given application. Many of these products are directed to anaerobe microbiology: the science of isolating, growing, and identifying microorganisms which thrive in environments devoid of oxygen.