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TalentBurst, an Inc 5000 company

Quality Control Analyst II

TalentBurst, an Inc 5000 company, Norton, Massachusetts, us, 02766

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TalentBurst, an Inc 5000 company provided pay range This range is provided by TalentBurst, an Inc 5000 company. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range $33.00/hr - $43.00/hr

Title Quality Control Analyst II

Job ID NORT000017

Location Norton, MA 02766

Duration 11 months contract (+Possibility of extension)

Shift & Coverage This is an onsite role in Norton, MA, with occasional responsibilities at other Client locations. Weekend coverage is required. First shift, Friday-Monday (4 x 10 hours), with initial Monday-Friday training.

Description The Quality Control Operations (QCO) Analyst II Contractor supports maintaining high standards of quality and compliance from development through commercialization. The role includes performing routine and non-routine testing, participating in data trending, investigations, and lab operations, and supporting method transfers, qualification/validation, verification, and implementation. This position enhances QC efficiency and effectiveness.

Key Responsibilities

Perform routine/non-routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in-process samples, product release, and stability studies following SOPs.

Support weekend lab operations and maintain training records.

Assist in lab equipment and inventory maintenance, including reagent and sample prep.

Review data timely and qualify as a data reviewer.

Perform operational assignments (raw material processes, environmental monitoring, in-process testing).

Contribute to updating controlled documents (SOPs, work instructions, test methods).

Follow internal policies, SOPs, and regulatory standards (GMP, GLP, ICH).

Participate in continuous improvement initiatives and cross-functional collaboration.

Support regulatory submissions, inspection readiness, and audits.

Qualifications

B.S. in chemistry, biology, biochemistry, or related field.

4-8 years of pharmaceutical/biotech experience in GMP QC or equivalent.

Experience in method transfer/implementation; understanding of method lifecycle management preferred.

Strong technical writing, data analysis, problem-solving, and organizational skills.

Excellent communication and teamwork.

Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred.

Seniority level Mid-Senior level

Employment type Contract

Job function Quality Assurance

Industries Pharmaceutical Manufacturing

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