Associate Scientist II, Quality Control

LGC Biosearch Technologies•Middleton, WI

5d•Onsite

About The Position

The Associate Scientist II, Quality Control supports and independently executes quality control activities for microbiological, next generation sequencing, biologics, and related products. The role applies established technical knowledge to perform and troubleshoot routine and moderately complex laboratory workflows, analyze and communicate results, support investigations and process improvements, and maintain compliance with the quality management system. This position works closely with Manufacturing, Process Development, Quality Assurance, and operational partners.

Requirements

Bachelor's degree in a relevant life sciences field such as molecular biology, microbiology, biochemistry, or a related discipline with relevant laboratory or industry experience—or an equivalent combination of education and applicable work experience.
Experience independently executing laboratory workflows in a regulated, production, biotechnology, pharmaceutical, or medical-device environment.
Demonstrated capability with applicable biological techniques, which may include cell-based assays, enzyme activity assays, ELISA, PCR, next generation sequencing, microbiology, and aseptic technique.
Demonstrated capability with applicable analytical techniques, which may include electrophoresis, chromatography, mass spectrometry, or spectroscopy.
Ability to operate standard laboratory equipment and to process, record, review, and interpret data using approved methods and good documentation practices.
Ability to follow SOPs and work instructions, recognize deviations or atypical results, perform initial troubleshooting, and escalate appropriately.
Experience contributing to investigations, process improvements, method updates, or controlled documentation.
Effective written and verbal communication skills and the ability to work successfully on cross-functional teams.
Working knowledge and proficiency with Microsoft Office, particularly Outlook, Word, and Excel.

Nice To Haves

Two or more years of relevant laboratory or industry experience in biotechnology, pharmaceutical, medical-device, or regulated manufacturing operations.
Experience with ISO 13485 or a comparable regulated quality management system.
Experience writing or revising SOPs, work instructions, test methods, or manufacturing protocols.
Experience supporting investigations, corrective and preventive actions, statistical analysis, method transfer, validation, or implementation of new technical processes.
Experience providing task-level training or technical guidance to peers.

Responsibilities

Independently execute routine and moderately complex QC testing and operational workflows to support production schedules, product release, development activities, and customer requirements
Identify assay, documentation, and process improvement opportunities through first-hand observation and data review; implement approved improvements and contribute technical input to change activities
Perform primarily tactical laboratory work with responsibility for planning assigned daily activities, prioritizing work, and completing defined technical assignments with limited day-to-day direction
Collaborate with local QC, Manufacturing, Process Development, Quality Assurance, and Operations partners; provide reliable technical information to support cross-functional work
Document laboratory activities and quality records clearly; summarize results, observations, risks, and recommended next steps to technical staff, peers, and leadership
Provide task-level guidance, peer support, and on-the-job training to less experienced team members when assigned
Own assigned workflows, test methods, equipment, or product-family activities within established procedures; support scheduling, readiness, documentation, and issue resolution
Apply working knowledge of microbiology, molecular biology, analytical methods, aseptic technique, and standard laboratory equipment; serve as a developing technical resource in assigned areas
Participate in and independently complete defined improvement projects, lean initiatives, investigations, and corrective or preventive action activities
Process, review, trend, and interpret test data using approved methods and good documentation practices; contribute to reporting of quality, productivity, right-first-time, and other relevant performance indicators
Perform laboratory and light manufacturing activities requiring repetitive hand movement, close visual work, standing, walking, and handling materials in accordance with the physical requirements below
Perform work in accordance with approved SOPs, work instructions, applicable regulatory requirements, ISO 13485 quality system requirements, safety expectations, and PPE policies
Perform other duties as required or assigned by management to meet business needs