Manufacturing Operator at Invitae (Greater Boulder Area, CO)
Invitae is dedicated to bringing comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Our team is driven to make a difference for the patients we serve. We are leading the transformation of the genetics industry by making genetic testing affordable and accessible for everyone to guide health decisions across all stages of life. We are passionate about what we do!
Operator 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.
- 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 equipment for processing operations
- Work with chemicals
- Wear the appropriate Personal Protective Equipment (PPE) when required.
- Adhere to Company policies and safety guidelines
- 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
- 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
- 3 to 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
In Colorado, our competitive compensation package includes a base salary starting from $23.00 per hour. We offer unlimited PTO and RSUs. In determining the final salary offered, we will evaluate a specific candidate's geographic location, education, skills, and experience.
Invitae offers a competitive total rewards package, which includes healthcare coverage, 401k, and a broad range of other benefits, outlined below:
- Health, dental, vision, short- and long-term disability, and basic life insurance coverage
- Paid time off, holiday pay, parental leave, and other health and wellness supports
At Invitae, we value diversity and provide equal employment opportunities (EEO) to all employees and applicants without regard to race, color, religion, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.