Tech Ops and Quality - Quality Control Analyst II

TalentBurst•Norton, MA

6h•Onsite

About The Position

The Quality Control Raw Materials / Sample Management (QC-RM/SM) Analyst II plays a role in supporting the department's 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.

Requirements

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)

Nice To Haves

Knowledge of LIMS, Excel, Word, and PowerPoint is helpful

Responsibilities

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 department's 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.