Overview
Sr eQMS Quality Specialist Jobs in Remote at iRhythm
Quality Assurance and Quality Control Specialist I
Full time 40 hrs/week
MUST BE LEGALLY AUTHORIZED TO WORK IN THE US.
VISA SPONSORSHIP IS NOT OFFERED.
RELOCATION ASSISTANCE IS NOT PROVIDED.
Company Overview:
Rocky Mountain Biologicals (RMBIO) is an international biotechnology company located in Missoula, Montana. RMBIO manufactures cell culture media, sera, transport media, and protein fractions for the global research, biopharma, medical, and clinical diagnostic industries. We are currently seeking a candidate to fill a permanent position as a quality assurance specialist.
Position Overview:
RMBIO is a fast-growing company and our ideal candidate is comfortable wearing many hats and assisting multiple departments. This position will report to the COO and is focused on laboratory testing, documentation, and regulatory compliance. This position is responsible incoming inspection, testing and release of raw materials and supplies and also for in process and final product testing. In addition, this position is also responsible for ensuring a company’s operating procedures (i.e., manufacturing processes) prevent mistakes and ensure predefined quality standards are met.
Job duties include but are not limited to the following:
Daily tasks including QC testing of in process and final product testing
Printing product labels, preparing paperwork for manufacturing runs, and compiling batch records.
Assist with ongoing projects like document organization, file maintenance, and audit preparation.
Assist warehouse department by reviewing incoming and outgoing product paperwork for correctness and completeness, obtain missing documentation if applicable, and assist with inventory counts as needed.
Communicate with warehouse and production team to confirm purchased products meet RMBIO requirements/specifications and are therefore suitable to use in manufacturing.
Assist other RMBIO departments with updating, revising, and issuing standard operating procedures (SOP’s) as needed.
Own maintenance of SOP’s related to the quality department.
Qualifications/skills
Bachelors degree required
Experience in the use of blood chemistry analyzer, flame photometer, UV-VIS spectrophotometric analysis, pH measurement, conductivity measurements and the use of common laboratory equipment. Experience in sterility testing, endotoxin testing and cell culture is also highly desirable.
Experience in environmental analysis of clean rooms
Self starter with demonstrated ability at self learning
Must be detail oriented
Excellent teamwork and communication skills
Self-motivated and takes pride in their work
Professional
Must be organized and able to prioritize tasks
Master’s Degree in biology, chemistry, or related field is a plus
Experience in manufacturing industry is a plus
Familiarity with cGMP (Good Manufacturing Practices), GDP (Good Documentation Practices), and GLP (Good Laboratory Practices) experience is a plus
Benefit Conditions:
Waiting period may apply
Work Remotely
No
Job Type: Full-time
Pay: Up to $24.00 per hour
Expected hours: 40 per week
Benefits:
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Day shift
Monday to Friday
Education:
Bachelor’s (Preferred)
Experience:
laboratory: 1 year (Required)
Shift availability:
Day Shift (Preferred)
Ability to Commute:
Missoula, MT 59808 (Required)
Ability to Relocate:
Missoula, MT 59808: Relocate before starting work (Required)
Work Location: In person
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Title: Sr eQMS Quality Specialist
Company: iRhythm
Location: Remote
