QC Associate Scientist, Quality Systems - Westminster CO, United States
Perform physical, chemical, and microbiological testing on raw materials, in-process materials, and finished product. Perform data analysis for routine and non-routine testing to ensure materials and products meet established specifications and requirements. Assist with implementation of Cerapedics’ quality program to ensure compliance with FDA regulations, ISO 13485 requirements, and other applicable regulations and standards.
Specific Functions and Responsibilities:
- Perform routine and non-routine laboratory testing of raw materials, in-process materials, finished goods using HPLC, BCA protein assays, Karl Fischer water content assays, cell culture assays, absorbance spectrophotometry, and other analytical or physical/mechanical testing.
- Investigate/troubleshoot assay problems and bring failures to the attention of management.
- Maintain living cells used for cell culture studies to ensure good health/viability and sufficient quantities needed for testing.
- Maintain and operate QC test instruments and equipment.
- Maintain QC test database and graphs, and monitor for trends.
- Assist with maintaining the document control system, e.g., Device Master Records (DMR), Device History Records (DHR), equipment calibration and maintenance records, etc.
- Perform routine transactions in SAP system for ordering lab/testing supplies and contract testing services, and updating materials/product QC acceptance status.
- Assist with writing, revising, and implementing manufacturing and Quality System procedures.
- Assist with writing study protocols, reports, and other documentation as needed.
- Assist with various projects or studies including process/equipment validations.
- Assist with NCR/CAPA investigations and documentation.
- Maintain lab notebook and batch records per GMP, GLP, and ISO standards.
- Perform routine QC inspections of incoming raw materials, in-process materials, and finished goods to ensure compliance with established specifications and requirements.
- Perform other reasonably related activities as requested.
- The above description outlines the most common job duties; however, it does not exclude other potential work assignments.
Desired Education or Formal Training:
Bachelor degree preferred and/or relevant laboratory experience in biology, chemistry, biochemistry, or medical technology. Experience in the medical device industry with knowledge of FDA GMP and GLP requirements, and the ISO 13485 standard is preferred.
Desired Qualifications: (knowledge, skills, abilities, initiative, judgment, etc.)
- General familiarity with techniques in cell biology, microbiology, and protein chemistry
- Ability to utilize a variety of mechanical and analytical instruments such as balances, viscometers, tensile testers, spectrometers, HPLC units, Karl Fischer titraters, microplate readers, etc.
- Familiarity with GMP, GLP, and ISO 13485 requirements.
- Solid organizational, time management, problem-solving, decision-making, and interpersonal skills.
- Ability to work accurately with attention to detail
- Ability to critically analyze data and proactively solve problems.
- Good written and oral communication skills. Must be able to effectively communicate (both verbally and writing) in individual and group situations.
- Ability to think and act independently.
- Ability to author, understand, and follow complex written procedures.
- Basic knowledge of fundamental statistical methods and analysis.
- Computer literate with knowledge of Microsoft Word, Excel, and Outlook.
Extent of Supervision:
Minimal supervision. Ability to independently rely on personal, knowledge, experience and judgment to plan and accomplish goals is a must.
Work Conditions / Physical Demands:
- Light manufacturing, laboratory, and warehouse operations
- Cleanroom/controlled environment operations
- Potential exposure to dust, noise, and odor
- Potential exposure to various chemicals
- Occasional light to moderate lifting
- Minimal travel, <5%
This position will be for 2nd shift Wed-Sunday.
We're an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.