QC Analyst I, Analytical

RoslinCT US•Hopkinton, MA

2h•$25 - $37

About The Position

RoslinCT is seeking a QC Analyst I, Analytical to support quality control activities for cell therapy manufacturing. The role partners with the analytical team and cross-functional groups to conduct incoming raw material inspections and sampling, prepare materials for external testing, evaluate certificates of analysis, and perform routine and non-routine testing on raw materials, in-process samples, and finished products. Testing may include pH, osmolality, appearance, visual inspection, cell counting, and related methods. The analyst authors and revises SOPs, material specifications, and test methods; assists with implementing new assay methodologies and instrumentation; and supports technology transfer, analytical method qualification, and routine GMP testing. The role also supports equipment installation and qualification, maintains laboratory equipment, and contributes to deviations, CAPAs, investigations, audits, inspections, and change controls while following applicable quality systems and cGMP requirements. This position is scheduled Monday through Friday on first shift, with a flexible schedule and occasional nights, weekends, and holidays to support 24/7 manufacturing operations. The work requires lifting up to 25 pounds, standing for extended periods, and performing repetitive tasks.

Requirements

Bachelor's degree in a scientific discipline.
0–2+ years of relevant raw material experience in a cGMP QC laboratory, or equivalent; raw material testing experience is a plus.
Ability to independently prioritize and manage activities.
Ability to prioritize objectives across multiple projects, meet scheduled timelines, and maintain flexibility and attention to detail.
Proficiency in MS Office applications and information technologies supporting documentation and data management systems.
Strong troubleshooting and problem-solving skills, with effective oral and written communication skills.
Experience working in a team environment and communicating effectively.

Nice To Haves

Knowledge of ANSI/ASQ Z1.4 sampling plans.
Hands-on experience with analytical techniques such as pH, osmolality, identifications, ELISAs, and cell-based assays.
Knowledge of cGMP, ICH, and FDA regulations.
Experience with LIMS.
Raw material testing experience.

Responsibilities

Perform QC inspection and sampling, as needed, of incoming raw materials and packaging components using detailed written procedures.
Author material specifications, SOPs, and other procedures to support the site Raw Material Program.
Perform material inspections using an electronic system.
Prepare and sample raw materials for shipment to external testing laboratories.
Evaluate certificates of analysis for chemicals, raw materials, and packaging components.
Perform routine and non-routine QC testing on raw materials, in-process samples, and finished products in support of cGMP manufacturing, as needed.
Operate and maintain laboratory equipment and instruments, ensuring proper calibration and cGMP compliance.
Support analytical equipment installation and qualification, including 21 CFR Part 11 compliance.
Collaborate with cross-functional departments as needed.
Follow Warehouse requirements for isolation of quarantined and released materials.
Apply technical knowledge to ensure testing is performed in a compliant manner.
Participate in internal and external audits, inspections, investigations, change controls, and CAPAs, as needed.
Work independently in a fast-paced team environment, meet deadlines, and prioritize work across multiple projects.
Communicate task completion, roadblocks, and needs to cross-functional peers and department management.
Perform other duties as assigned by management.