cGMP Manufacturing Associate I/II - IVD

| Greater Boulder Area | Hybrid
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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!

 Position Summary:

This position is primarily responsible for performing manufacturing activities in our specialty IVD manufacturing lab. This position works in a team based, environment to complete the manufacturing tasks required. The majority of day-to-day activity will be focused on manufacture, inspection and labeling of our product. In addition to daily manufacturing activities this role will assume team lead tasks as required and provide crucial feedback on new process development and assist in performing operational system validations.

 Responsibilities:

Job performance will involve a variety of activities including:

  • Manufacture product as specified in controlled manufacturing procedures, and in compliance with cGMP regulations and guidelines
  • Generation of bulk material and aliquoting liquid reagents
  • Weighing out volumetric and solid materials
  • Prepare laboratory, clean and maintain the manufacturing area per company specifications
  • Prepare equipment for manufacturing operations and operate manufacturing lab equipment as trained
  • Accurately completes documentation of manufacturing batch records and other approved attachments, using Good Documentation Practices
  • Follow standard operating procedures and work instructions when completing tasks detailed in manufacturing batch records
  • Assists in the preparation of reports and other documentation as applicable to the scope of manufacturing
  • Accurately update applicable work order data into an ERP system
  • Additional responsibilities as assigned
  • Enforce Company policies and safety guidelines
  • Review, understanding, and compliance with Invitae HIPAA Security policies and procedures
  • Safeguarding the privacy and security of protected health information and European Union personal data
  • Processing and handling of European Union personal data only as advised by Invitae for purposes of personalized molecular pathology

Furthermore, the responsibilities listed above the Associate II position is responsible for the below:

  • Assuming team lead responsibilities when needed and assisting the team lead in the following tasks as advised:
  • Training new employees
  • Performing review of GMP documentation
  • Identifying and monitoring constraints to manufacturing schedule
  • Ensuring equipment calibration and preventative maintenance services are completed and documented with the quality system for compliance purposes
  • Implementation of new equipment and equipment documents
  • Recognizing and communicating deviations in procedure
  • Ensuring all consumables are organized and submits restock requests as required
  • Confirming movement of consumables and finished product into appropriate locations
  • Documentation:
  • Initiates temporary changes and NCRs as needed
  • Participates in process improvement and new process development
  • Assists in updating manufacturing documentation to reflect current practices
  • Works with QA to investigate deviations, perform risk assessments and close out NCRs

 Experience:

  • 4+ 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
  • Basic understanding of cGMP requirements per 21CFR820
  • Understanding of ISO 13485
  • Previous experience with manufacturing of class 2 and preferably class 3 Medical Device is preferred
  • Experience with aseptic or molecular biology technique is also preferred

 Key Attributes:

  • Demonstrates good verbal, listening and written communication skills
  • Strong attention to detail
  • Ability to develop and be a phenomenal partner with individuals representing a wide diversity of subject areas and levels of sophistication in a collaborative environment
  • A 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 efficiently and cooperatively to improve the success of the projects and maintain positive relationships within all parts of the company
  • Self-starter driven to perform with the ability to prioritize and execute tasks

 Education:

  • Degree requirement may be waived with relevant experience in an FDA regulated, controlled production environment, including Manufacturing, Quality Control, Quality Assurance, and/or Materials Management
  • Bachelor’s degree in a scientific field or 2+ years of relevant manufacturing experience in an FDA regulated, controlled production environment
  • Technical accuracy and ability to perform mathematical and chemical calculations preferred



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.

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Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

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