Quality Control Associate
Paragon Genomics is a fast-growing life sciences company developing advanced reagents and assay kits for next-generation sequencing (NGS). We’re seeking a Quality Control Associate who demonstrates technical knowledge and significantly contributes to the overall operations of the lab. The ideal candidate has knowledge of and experience with current Good Manufacturing Practice (cGMP) and Standard Operating Procedures (SOPs). The ideal candidate will have wet-lab technical skills in NGS library preparation, target enrichment, or molecular biology, in general. This position will interact closely with colleagues in research and development, manufacturing, sales, operations, applications, and accounting. This is a contract-to-hire position.
- Perform quality control of reagents, panels, and kits.
- Initiate, prepare and revise technical documents and reports including validation plans, SOPs, and more.
- Conduct tests and inspections of products, services, or processes to evaluate quality or performance.
- Support maintenance and compliance of quality control, incoming inspection, and operational areas.
- Implement and ensure strict adherence to quality control and quality assurance measures of NGS assays. Ensure adherence to all regulatory guidelines.
- Calibrate, validate, and maintain laboratory equipment.
- Assist Quality Assurance as needed.
- Generate QC procedures/ documents.
- Perform RCA and NCR's.
- Additional duties and responsibilities may be assigned.
Qualifications and Skills
- BS degree in Biological Science or another relevant degree, with a minimum of 1-2 years of relevant industry experience or an Associate's degree with 4+ years of relevant industry experience in a quality control or lab technician role.
- Strong molecular biology laboratory skills. Experience in multiplex PCR, sample preparation, ctDNA, and/or dPCR/qPCR is highly valued.
- Knowledge of ISO, Good Document Practices (GDP), and Good Manufacturing Practices (GMP) a plus.
- Good computer skills and comfort in using computers for all aspects of MFG, including experience with MS Office (Excel and Word). WooCommerce or other order fulfillment software a plus.
- Excellent project management and organizational skills, with attention to detail.
- Excellent oral and written communication skills. Ability to communicate professionally with vendors, internal customers, and sales professionals regarding quality and purchasing issues.
- Outstanding interpersonal skills, highly collaborative within a multi-discipline team, and contribute to a supportive and positive work environment.
- Dedicated, self-motivated, and engaged to learn new methodologies or provide recommendations for optimization.
- Excellent critical thinking skills. Uses logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.
- Demonstrated ability to organize, document, and communicate scientific data.
- Must be able to multi-task, perform under pressure, and adapt to changes (in priorities and timelines) in a fast-paced and quickly changing environment.
- Must be able to stand for long periods of time while performing duties.
- Must be able to work independently and safely in a lab environment.
- Must be able to lift up to 20 lbs.
This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.
Paragon Genomics Inc. is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Headquartered in the San Francisco Bay Area, Paragon Genomics is a fast-growing precision medicine company. Our patented targeted sequencing technologies CleanPlex DNA, CleanPlex RNA, and CleanPlex UMI provide comprehensive solutions to precision diagnostics in oncology, infectious disease, inherited disease, reproductive health, neurology, cardiology, and many other applications. Our technologies and products have been adopted by hundreds of prominent Next-Generation Sequencing (NGS) labs globally. With our platforms, we can efficiently and rapidly produce unique and customized next-generation sequencing (NGS) assays to meet the needs of researchers, testing labs, and biopharma precision medicine projects.
The Company was selected by a distinguished panel into the California Life Science Association F.A.S.T. Program in March 2016 and was accepted into the prestigious Stanford StartX Medicine Accelerator Program in September 2016.
Paragon Genomics offers a competitive and comprehensive employee benefits package, including medical, dental, vision, and life insurance, flexible spending account, 401K, paid time off, and stock options.