Quality Control Scientist

TekWissen•Plainville, MA

3d•Onsite

About The Position

Our client is seeking a Quality Control Bioanalytical Scientist to join their Quality Control Bioanalytical Laboratory team supporting cGMP clinical and commercial manufacturing. This position is responsible for performing routine and complex bioanalytical testing, troubleshooting laboratory methods and equipment, reviewing data and documentation, supporting method transfers and validations, and maintaining compliance with cGMP and applicable regulatory requirements. The ideal candidate has hands-on QC laboratory experience, strong bioanalytical testing skills, and the ability to work effectively in a fast-paced manufacturing environment.

Requirements

Bachelor's degree in Biology, Molecular Biology, Analytical Chemistry, or a related scientific discipline.
1 to 3+ years of relevant industry or laboratory experience is required.
Prior QC experience in a manufacturing environment is very highly desired.
Hands-on experience performing laboratory testing and troubleshooting, preferably within a GxP/cGMP-regulated Quality Control laboratory.
Experience with routine and complex bioanalytical methods and laboratory instrumentation.
Experience with method transfer, verification, validation, or qualification activities.
Knowledge of cGMP practices, QC laboratory operations, quality systems, data integrity, and inspection readiness.
Experience preparing technical documentation such as SOPs, Work Instructions, Forms, and quality records.
Strong analytical, troubleshooting, and problem-solving skills.
Strong written and verbal communication and interpersonal skills.
Ability to work independently with minimal to moderate supervision while managing multiple priorities.
Strong attention to detail, organization, accountability, and adaptability.
Proficiency in English, both written and verbal.

Responsibilities

Perform timely, Right First Time (RFT) cGMP QC testing and documentation for in-process, release, stability, STAT, and critical utility samples.
Perform and troubleshoot routine and complex bioanalytical assays and laboratory testing, including TOC/Conductivity, pH, osmolality, FTIR, A260, cell count/viability, ddPCR/qPCR, VGT, TCID50, icIEF, CE-SDS, SDS-PAGE, ELISA, UHPLC, and other applicable assays.
Support method transfer, qualification, validation, verification, and troubleshooting activities for QC methods.
Support compendial method verification and serve as a technical resource as assigned.
Perform and support laboratory equipment maintenance, calibration, troubleshooting, and new equipment implementation.
Review laboratory data and documentation to ensure accuracy, data integrity, and cGMP compliance.
Perform routine laboratory operations, including reagent preparation, material stocking, laboratory cleaning and organization, and logbook completion and review.
Support reference standard and critical reagent programs, including inventory management and trending.
Author and revise SOPs, Work Instructions, Forms, and other technical documents.
Prepare and manage quality records, including deviations, OOS, CAPAs, LIRs, and related documentation.
Support laboratory inspection readiness and participate in audits and inspections as needed.
Maintain required training and provide training to other team members when assigned.
Utilize laboratory and quality systems, including Empower, SampleManager LIMS, TrackWise, D2, Microsoft Office, Smartsheet, and other applicable systems.
Participate in continuous improvement initiatives and cross-functional projects.
Identify and troubleshoot technical or laboratory issues and communicate solutions effectively.
Collaborate with QC, manufacturing, facilities, maintenance, automation, and other cross-functional teams.
Follow cGMP, laboratory safety, quality, and regulatory requirements at all times.