cGMP Manufacturing Associate - WES

| Greater Boulder Area
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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.

POSITION SUMMARY:
This position is primarily responsible for performing manufacturing activities in Invitae's specialty manufacturing lab.  The majority of day-to-day activity will be focused on manufacture, inspection, labeling, and packaging of our product.  The Manufacturing Associate 1 is responsible for maintaining manufacturing space cleanliness. This role will also provide essential feedback on new process development and assist in performing system validations. 
RESPONSIBILITIES:
  • 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 specifications
  • Labeling, organizing and maintaining consumables inventory
  • Generation of bulk material and aliquoting of non-hazardous liquid reagents
  • Operate manufacturing, manufacturing-support and lab equipment as trained
  • Clean, prepare and assemble equipment for processing operations
  • Movement of consumables and finished product into appropriate locations
  • Adhere to Company policies and safety guidelines
  • Documentation:
    • 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
      • Ensures equipment calibration and preventative maintenance services are completed and documented in compliance with quality system
  • Additional responsibilities as assigned
  • Review, understand, and comply with ArcherDX HIPAA Security policies and procedures.
EXPERIENCE:
  • 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 plus.
KEY ATTRIBUTES:
  • 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 execute tasks.   
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 Manufacturing, Quality Control, Quality Assurance, and/or Materials Management.
  • Basic understanding of cGMP requirements per 21CFR820 preferred but not required.
  • Basic understanding of ISO 13485 preferred but not required.
  • Technical accuracy and ability to perform mathematical calculations.

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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Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • RLanguages
    • D3JSLibraries
    • jQuery UILibraries
    • Twitter BootstrapLibraries
    • DjangoFrameworks
    • PostgreSQLDatabases

Location

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

An Insider's view of ArcherDX

What’s the vibe like in the office?

Collaborative - when I walk through the ArcherDX office at any time of day, I can see cross-functional collaboration in action. Our team members are constantly connecting in structured and unstructured meetings to solve problems and achieve goals.

Sarah

Corporate Recruiter

How do you collaborate with other teams in the company?

Collaboration between functional groups is key to the Logistics team's success at Archer. Working closely with Sales, Manufacturing, Assay Development, Customer Support, Finance and QA allows us to provide better customer service by improving our processes, troubleshoot, brainstorm new ideas, learn from each other and share our best "dad" jokes.

Judy

Logistics Manager

How do you empower your team to be more creative?

Creativity requires a break from the routine and the screen. Here at Archer the team gets creative through walks to the food trucks, lunch runs, climbing gym sessions or a few end of the week craft brews. Some of our best algorithms were developed or refined on the climbing gym mat.

Aaron

VP of Bioinformatics and Commercial Development

What are ArcherDX Perks + Benefits

ArcherDX Benefits Overview

ArcherDX offers a competitive and generous benefit package including:

• Medical PPO or HMO and Dental-82% of monthly premium covered by the company
• Optional vision, life, FSA, dependent care plans
• Basic AD&D, Short and Long Term disability-covered 100% by the company
• 160 hours PTO per calendar after three months of service
• 6-weeks parental leave covered 100% by the company
• 401K with company match with potential of up to $2000/year
• 2019 bonus - 5% based on company objectives (for non-commissioned employees)
• Company stock options for all employees
• Tuition Reimbursement
• Ecopass

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Diversity
Documented equal pay policy
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Remote Work Program
Our remote work program includes work from home on occasion as needed.
Family Medical Leave
Company sponsored family events
Archer sponsors family oriented events annually. This year, we had our summer picnic at the Boulder Reservoir.
Vacation & Time Off Benefits
Generous PTO
Paid Holidays
Perks & Discounts
Beer on Tap
Casual Dress
Commuter Benefits
Company Outings
Archer hosts company outings Semi-annually.
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Our tuition reimbursement plan offers an annual max of $5250.
Cross functional training encouraged
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