Sr. QC Associate

Salary Range $70,304 - $85,000 annually.

Job Summary:

The Senior QC Associate independently performs all activities related to the qualification of EntroGen products. The successful candidate will perform QC testing and data analysis focused on ensuring the integrity and quality of products throughout the manufacturing process. This role is critical to ensuring the accuracy, consistency, and compliance of our diagnostic products.

Essential Duties and Responsibilities:

·        Independently perform QC testing & data analysis to ensure product performance meets specs.

·        Lead investigation, troubleshooting and root cause analysis for non-conforming materials or out of

spec results.

·        Generate comprehensive data reports for analytical QC testing, investigations, and data collection in

accordance with regulatory requirements

·        Author, review, and validate SOPs and associated forms for QC and Manufacturing.

·        Devise and implement continuous improvement initiates.

·        Assist in training for QC Associates and QC Assistants.

·        Assist in cross-functional support as QC subject matter expert for the production, research &

development, and technical support departments.

·        Prepare quality control reagents and controls for use in testing.

·        Operate, maintain and calibrate laboratory equipment and instruments in accordance with QC

protocols.

·        Receive, inspect, and organize incoming shipments and materials.

·        Control and monitor inventory of QC materials and lab supplies.

·        Provide general laboratory support including cleaning, organization, and supply restocking.

·        Provide support to the manufacturing department as necessary to maintain work flow.

·        Package and ready final product for shipment.

·        Prepare buffers and laboratory decontamination solutions.

·        Fill supply request forms for in house product transfer to R&D.

·        Performs other related duties as assigned.

Qualifications and Required Skills:

·        Bachelors degree (BS) in Biology, Life Sciences, or a related field.

·        5 years of related experience.

·        Previous hands-on experience with molecular biology techniques (qPCR and extractions).

·        Previous experience with CAPA, deviations, change control, and document management systems.

·        Strong organizational skills with excellent attention to detail.

·        Effective communication skills and the ability to work in a team-oriented environment

·        Proficient in using Microsoft excel.

·        Ability to lift up to 50 lbs, and perform physical tasks such as standing, bending, and twisting for

extended periods.

·        Must be authorized to work in the U.S for any employer.