Quality Control Associate (ADX-04-21)
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Quality Control Associate (ADX-04-21)
COMPANY SUMMARY:
In October 2020, Invitae Corporation (NYSE: NVTA) combined with ArcherDX, a genomic analysis company specializing in cancer diagnostics and monitoring, to create a leading comprehensive medical and cancer genetics company. As a combined company, Invitae, is bringing world-class genetic testing and diagnostics into mainstream medicine to improve healthcare for billions of people. Our goal is to aggregate the world’s genetic tests into a single service with higher quality and accuracy, faster turnaround time and actionable results. Learn more at invitae.com and archerdx.com.
POSITION SUMMARY:
Evaluates and implements protocols and methods to inspect and test in-process raw materials and finished products and ensure that they are in compliance with internal and external safety, quality and regulatory standards requirements for distribution. Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary. Develops processes and tests to determine that appropriate quality control analysis is being performed. Prepares documentation for inspection and testing procedures. Evaluates and analyzes the efforts in organizing, documenting and interpreting inspection support documents and records. May assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO).
RESPONSIBILITIES:
Evaluates and implements protocols and methods to inspect and test in-process raw materials and finished products and ensure that they are in compliance with internal and external safety, quality and regulatory standards requirements for distribution. Performs analysis and identifies trends in the inspection of finished products, in-process materials and bulk raw materials, and recommends corrective actions when necessary. Develops processes and tests to determine that appropriate quality control analysis is being performed. Prepares documentation for inspection and testing procedures. Evaluates and analyzes the efforts in organizing, documenting and interpreting inspection support documents and records. May assure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO).
RESPONSIBILITIES:
- Job performance will involve a variety of activities including:
- Execution of work instructions testing in-process raw, sub-assembly, and top-level materials
- Critical analysis of data ensuring compliance with standards
- Generation of data reports and release of materials
- Adherence to safety and quality laboratory standards
- Upkeep of personal training and associated records
- Maintenance of laboratory material stocks and initiation of re-orders
- Execution of validation protocols
- Identification of non-conforming material and subsequent report initiation and generation
- Review, understanding, and compliance with ArcherDX 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 directed by ArcherDX for purposes of personalized molecular pathology.
EXPERIENCE:
- 2 or more years of experience in a laboratory setting utilizing micro-pipettes a plus
KEY ATTRIBUTES:
- Drive and determination
- Ability to work in a fast paced and dynamic environment
- 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
- Strong communication and presentation skills
- Self-starter
- Driven to perform
- Self-directed: needs little explicit direction
- Able to organize, prioritize, and delegate tasks to efficiently move projects forward.
EDUCATION:
- Bachelor’s degree in science-related field required
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