cGMP Manufacturing Associate - PSP

Company: Invitae
Location: Boulder
Posted on: June 12, 2021

Job Description:

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/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 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
• 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 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.

Keywords: Invitae, Boulder , cGMP Manufacturing Associate - PSP, Other , Boulder, Colorado