Quality & Regulatory Affairs
Molecular Diagnostics Quality Analyst
Overview of the role:
The Molecular Diagnostics Quality Analyst is responsible for incoming, in-process, and final product acceptance inspection and/or testing. The Molecular Diagnostics Quality Analyst will perform the functions of sampling, inspecting, isolating nucleic acids, measuring, testing, analyzing data, recording, and reporting laboratory results performed for acceptance activities as directed for specific assays/products.
Responsibilities also include assisting in the identification, development, and validation of appropriate test methods. In addition, the Molecular Diagnostics Quality Analyst may serve as Quality representative on process development and validation project teams when appropriate.
Essential duties and responsibilities:
- Performs incoming material acceptance activities, inspection and/or testing, per required specifications;
- Assists in establishment of incoming quality control (IQC) specifications and requirements;
- Performs required testing of in-process material and product;
- Performs final product release evaluation by performing high-complexity molecular diagnostic testing including, but not limited to PCR or sequence-based methods;
- Participates in QC test method validations;
- Follows procedures for sample/product handling, processing, analysis, and recording of required data according to controlled documents;
- Maintains complete and effective documentation in accordance with MolecularMD policies and good documentation practices;
- Raises regulatory/compliance concerns to the Laboratory Director, Director of Quality and Regulatory Affairs, or Director of Operations;
- Models compliance with clinical laboratory regulatory policies, all MolecularMD policies, contractual procedures for each MolecularMD client, safety and regulatory work practice guidelines as defined in the Quality Management System, the Chemical Hygiene Plan, confidentiality and HIPAA agreements, and all applicable state and federal regulations and requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to perform essential job duties with or without reasonable accommodation, and without posing a direct threat to the safety or health of employee or others
- Must have experience performing molecular diagnostic assays (qPCR, RT-qPCR, Sanger sequencing, etc.)
- Prior quality experience strongly preferred
- Possess the ability to exercise sound judgment and make decisions based on accurate and timely analyses
- Ability to work independently, but collaboratively
- Strong internal customer service and interpersonal communication skills
- Some data analysis and/or statistical software experience required
- Bachelors degree (BS/BA) in a relevant science, and 2 plus years of relevant experience or a minimum of 5 years of experience in clinical molecular diagnostics assay use.
- Requires advanced specialized computer skills that require mastery of applicable software in such fields as technical writing, statistics and web based training.
If you are interested in joining our team and would like to be considered for a future job opening, please email your resume to: email@example.com