Job Description

Industry: Pharmaceuticals

Title: Quality Control Analyst II

Job ID: NORT000017

Location: Norton, MA 02766

Duration: 11 months contract (+Possibility of extension)

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

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