Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials
Job Description
Position Summary:
Responsible for all quality control aspects of finished product testing. Ensure that performance of finished product is in compliance with testing standards per IFU and SOP's in addition to customer requirements and regulating agencies' guidelines. Documentation control duties per Quality Assurance compliance requirements.
Key Responsibilities:
Review and maintain product compliance specifications, documentation control.
Gain proficiency on all testing areas.
Documentation of testing results and determining disposition.
Maintain consistency in training in Master Control.
Establish and maintain SOP criteria for inspection/testing.
Responsible for maintaining department equipment and requesting consumables as needed.
Exercise and monitor GMP and GLP compliance in work environment.
Work closely with Quality Assurance department as a quality team.
Execute Stability Study testing in accordance with QA requirements.
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.
Work closely with a team in a fast paced laboratory setting.
Understand and exercise all safety requirements and procedures.
Assists in maintaining standards in accordance with GMP's/SOP's and ISO regulations.
Participate in achieving department goals.
Support all company policies.
Performs other duties as assigned.
Minimum Requirements/Qualifications:
Possess at least a 4-year degree in the biological sciences. Must have course work in microbiology with a 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.
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 regarding 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 in English.
Able to adapt and to learn new procedures and to maintain a scientific and objective approach.
Must be available to work overtime when needed.
Self-motivated, highly responsible and possess a good teamwork spirit.
Excellent verbal and written skills in English.
Negative TB Test
Pass Ishihara(Color Blind) Test
Must be able to flex between Mon-Thurs or Tues-Friday depending on work requirements.
