Reagent Manufacturing Associate I

• →Support equipment qualification activities, including IQ/OQ/PQ, preventive maintenance, routine maintenance, basic troubleshooting, and required documentation in accordance with ISO 13485 requirements.
• →Assist with planning and execution of validation activities, including reagent stability studies, shelf-life extension testing, documentation, and data review.
• →Perform reagent manufacturing activities, including formulation, filling, labeling, assembly, packaging, material handling, in-process quality checks, and accurate batch documentation for RUO and IVD products.
• →Receive, inspect, label, store, stage, and reconcile raw materials, components, and finished goods while maintaining accurate lot control, FIFO usage, traceability, and inventory records.
• →Prepare work orders, stage materials, support line setup, verify material identity and quality, print labels using controlled templates, and perform manual or semi-automated operations such as pipetting, capping, and sealing tubes and 96-well plates.
• →Perform in-process and lot-release QC testing for clinical diagnostic reagent manufacturing, support data analysis, review results for accuracy and completeness, and escalate issues as appropriate.
• →Follow SOPs and work instructions, maintain organized manufacturing records, and assist with drafting or revising SOPs, batch records, work instructions, and material specifications.
• →Assist in identifying, documenting, escalating, and supporting resolution of nonconformance events, deviations, CAPAs, and related root cause investigations.

• Bachelor's degree in Biology, Molecular Biology, Genetics, Chemistry, Biochemistry, or a related field preferred. An Associate's degree in a life sciences field, or High School Diploma/GED with relevant experience, may be considered.
• 0–2 years of relevant laboratory, reagent manufacturing, life sciences production, or regulated manufacturing experience.
• Basic hands-on molecular biology experience preferred, including DNA/RNA purification, nucleic acid handling, PCR, qPCR, and/or related techniques.
• Exposure to NGS workflows, reagent manufacturing, or regulated environments such as ISO 13485, 21 CFR Part 820, cGMP, and/or GDP is a plus.
• Strong attention to detail, willingness to follow established procedures, and commitment to accurate documentation and record-keeping.

• Ability to work independently and collaboratively with team members.
• Highly goal-driven and have demonstrated the ability to effectively prioritize and focus on time-sensitive objectives.
• Strong problem-solving skills.
• Strong teamwork and motivation skills are essential.
• Strong organizational, record-keeping and communication (verbal and written) skills. 
• Strong work ethic to generate high quality work under tight deadlines.

The above job description is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. Responsibilities and duties may change or be adjusted to meet the needs of the company, and additional duties may be assigned as necessary. The job description is subject to change at any time at the discretion of Karius.

 At Karius, we value a diverse and inclusive workplace and provide equal employment opportunities for all applicants and employees and are committed to honor and invest in the full diversity of people, in our hiring, recruiting and development of employees across the Company.  All qualified applicants for employment are encouraged to apply and will be considered without regard to an individual’s race, color, sex, gender identity and gender expression (including transgender individuals who are transitioning, have transitioned, or are perceived to be transitioning to the gender with which they identify), religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other basis protected by federal, state or local laws. If you are unable to submit your application due to a disability, please contact us at recruiting@kariusdx.com and we will accommodate qualified individuals with disabilities.