Job Posting: Analyst I, Quality Control Operations

Onsite - Norton, MA

Overview

We are seeking a detail-oriented and motivated Analyst I, Quality Control Operations to join our team onsite in Norton, MA. In this role, you will contribute to the execution of analytical assays and support daily lab operations to ensure product quality and regulatory compliance across development and commercialization phases.

Key Responsibilities

Execute routine and non-routine analytical assays for raw materials, in-process samples, product release, and stability studies under supervision.
Maintain accurate and current training records and ensure timely completion of tasks to support departmental timelines and quality objectives.
Assist with laboratory operations, including equipment maintenance, reagent preparation, and sample handling.
Accurately document experimental data in compliance with GxP standards; participate in data review as appropriate.
Support the revision and updating of controlled documents (SOPs, test methods, work instructions).
Ensure adherence to internal policies, SOPs, and external regulatory guidelines (GMP, GLP, ICH).
Contribute to continuous improvement efforts, especially in enhancing laboratory efficiency and reliability.
Collaborate effectively with Quality Control and cross-functional teams to support operational goals.
Engage in ongoing training to enhance skills in analytical techniques and regulatory compliance.

Qualifications

Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related discipline.
0-2 years of experience in a GMP/GLP-regulated laboratory setting; pharmaceutical or biotech industry experience preferred.
Familiarity with analytical techniques related to raw material, in-process, release, and stability testing preferred.
Strong documentation and attention to detail with a high level of accuracy and compliance focus.
Basic understanding of regulatory requirements (GMP, GLP, ICH).
Effective communication and collaboration skills.
Ability to follow detailed instructions and work effectively under supervision.

Location:

This role is 100% onsite in Norton, MA. Occasional travel to Cambridge, MA may be required.

Advanced Clinical

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