Tech Ops and Quality Quality Control Analyst II

Title:Analyst II Quality Control Raw Materials
Location:Norton MA
Duration: 12 Months

Overview
The Quality Control Raw Materials / Sample Management (QC-RM/SM) Analyst II plays a role in supporting the departments efforts to maintain the highest standards of quality and compliance from development through to commercialization. This includes testing evaluation and release of raw materials used in manufacturing to ensure compliance with regulatory requirements internal specifications and industry standards. By ensuring these critical activities are executed within project milestones and timelines the Analyst II contributes to manufacturing operations by ensuring timely and accurate testing of incoming raw materials maintaining documentation and contributing to continuous improvement initiatives within the laboratory.

This position is onsite and will be primarily located in Norton MA. There may occasionally be responsibilities at a secondary location in Cambridge MA or off-shift as required by business need.

Key Responsibilities (including but not limited to):

• Perform routine and non-routine inspection of raw materials.
• Maintain up-to-date training records adhere to the inspection schedule and ensure the timely completion of all assignments to support the seamless operation of QC activities and uphold the departments commitment to meeting project timelines and quality metrics.
• Accurately document all results in laboratory notebooks LIMS or other controlled systems in compliance with GMP standards. Review as needed to ensure timely and efficient material availability.
• Participate heavily in raw material qualification programs including vendor/supplier qualification and material risk assessments.
• Collaborate cross-functionally with other organizational functions including Manufacturing Materials Management and Quality Assurance to ensure raw material availability and release timelines.
• Contribute to the revision and updating of controlled documents including SOPs work instructions and test methods to ensure continuous improvement and compliance with ALNY requirements
• Participate in inspection readiness activities as well as supporting onsite audits and inspections as needed.

Qualifications

• B.S. in chemistry biology or biochemistry or related scientific field ; Associates Degree Biotech Certificate or equivalent considered
• Pharmaceutical/Biotech industry experience with 3-6 years in a regulated laboratory setting Quality Control or equivalent relevant experience
• Ability to work independently with attention to detail in an environment where priorities shift
• Good communication and teamwork abilities capable of working effectively in a collaborative environment
• Ability to stand for extended periods of time and occasionally lift raw materials (up to 25lbs)
• Knowledge of LIMS Excel Word and PowerPoint is helpful

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Why TalentBurst
At TalentBurst we deliver more than talent we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision transparency and results we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits including medical dental vision and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.