cGMP Manufacturing Associate - PSP
Posted on: June 12, 2021
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
This position is primarily responsible for performing
manufacturing activities in Invitae/Archer's specialty IVD
manufacturing lab. The majority of day-to-day activity will be
focused on manufacture, inspection, labeling, and packaging of
Invitae/Archer product. The Manufacturing Associate 1 is
responsible for maintaining manufacturing space cleanliness. The
operations include handling cryogenic materials so attention to
safety is critical. This role will also provide essential feedback
on new process development and assist in performing system
- Manufacture product as specified in controlled manufacturing
procedures, and in compliance with regulations and guidelines:
- Cleaning, sterilizing and preparing laboratory on a daily
basis/Maintain the manufacturing area per company
- Labeling, organizing and maintaining consumables inventory
- Generation of bulk material and aliquoting of non-hazardous
- Operate manufacturing, manufacturing-support and lab equipment
- Clean, prepare and assemble equipment for processing
- Movement of consumables and finished product into appropriate
- Adhere to Company policies and safety guidelines
- Assist in the preparation of reports and other documentation as
applicable to the scope of manufacturing
- Accurately complete documentation of manufacturing batch
records, using Good Documentation Practices
- Initiate deviations, Risk Assessments and NCRs
- Accurately update applicable WO data into an ERP system
- Responsible for ensuring inventory supply levels are maintained
and puts POs in as necessary
- Ensures equipment calibration and preventative maintenance
services are completed and documented in compliance with quality
- Additional responsibilities as assigned
- Review, understand, and comply with ArcherDX HIPAA Security
policies and procedures.
- 1+ years' experience in an operations, manufacturing, or
similar environment preferred.
- Good Manufacturing Practices (GMP) Experience at an FDA
regulated biotech, pharmaceutical, or medical device manufacturer
is a plus.
- Previous experience with manufacturing of class 2 and
preferably class 3 Medical Device also is a plus.
- Experience with aseptic or molecular biology technique is a
- Demonstrates good verbal, listening and written communication
skills. Strong attention to detail.
- Ability to foster and maintain relationships with individuals
representing a wide diversity of disciplines and levels of
sophistication in a collaborative environment.
- Deadline and deliverable driven individual with an ability to
adapt to unexpected or abnormal results or situations.
- Ability to participate with others as a member of the team to
ensure that demanding and difficult projects are handled smoothly
and cooperatively to enhance the success of the projects and
maintain strong relationships within all parts of the company.
- Self-starter driven to perform with the ability to organize and
- 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
Manufacturing, Quality Control, Quality Assurance, and/or Materials
- Basic understanding of cGMP requirements per 21CFR820 preferred
but not required.
- Basic understanding of ISO 13485 preferred but not
- Technical accuracy and ability to perform mathematical
In Colorado, our competitive compensation package includes a
base salary starting from $21.64 per hour. 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.
Keywords: Invitae, Boulder , cGMP Manufacturing Associate - PSP, Other , Boulder, Colorado
Didn't find what you're looking for? Search again!