cGMP Manufacturing Associate I/II (ADX-119-20)
Manufacturing Associate I/II (ADX-119-20)
THE COMPANY: ArcherDX, Inc. - www.ArcherDX.com
ArcherDX is advancing molecular diagnostics with a robust technology platform for genetic mutation detection by next-generation sequencing. By combining patented Anchored Multiplex PCR (AMP™) chemistry in an easy-to-use, lyophilized format and powerful bioinformatics software, the Archer® platform enhance genetic mutation identification. ArcherDX provides oncology-focused research products and is pursuing regulatory approval for multiple companion diagnostic assays. ArcherDX is headquartered in Boulder, Colorado. Learn more at www.archerdx.com and follow @ArcherDXInc on Twitter, Facebook and LinkedIn.
POSITION SUMMARY:
Associate level position for manufacturing medical devices in accordance with controlled procedures (SOPs) in compliance with Good Manufacturing Practice (GMP) regulations and current GMP (cGMP) guidelines. Manufactures solutions, labels and fills containers, labels and assembles kits. Compiles auditable electronic or paper records of manufacturing, maintains equipment logs and monitors supplies.
RESPONSIBILITIES:
- Manufacture product as specified in controlled manufacturing procedures, and in compliance with cGMP regulations and guidelines
- Accurately complete documentation in cGMP manufacturing batch records, using Good Documentation Practices
- Operate manufacturing, manufacturing-support and lab equipment as trained
- Maintain the cGMP Manufacturing area per Company specifications
- Assist in the preparation of reports and other documentation as applicable to the scope of manufacturing
- Clean, prepare and assemble the equipment for processing operations
- Work with chemicals
- Wear the appropriate Personal Protective Equipment (PPE) when required.
- Adhere to Company policies and safety guidelines
PREFERRED QUALIFICATIONS:
- Bachelor’s degree in a relevant scientific discipline
- 3-4 years relevant manufacturing experience in an FDA regulated, controlled environment
- Experience with aseptic or molecular biology technique
- Knowledge of Good Manufacturing Practice and other applicable standards
- Skilled with good documentation practices
- Prior work within a GMP quality system
EDUCATION:
- High School Diploma or A.S. degree in biological or physical science. Degree requirement may be waived with relevant experience in an FDA regulated, controlled production environment, including cGMP Manufacturing, Quality Control, Quality Assurance, and/or Materials Management
Or
- Bachelor’s degree in a scientific discipline and 1-2 years of relevant manufacturing experience in a FDA regulated, controlled production environment
- Skill with aseptic, cleanroom or molecular biology technique
- Technical accuracy and ability to perform mathematical calculations
- Strong interpersonal skills and the ability to work effectively and efficiently in a team environment
- Excellent oral and written communication skills