Tech Ops and Quality - Quality Control Analyst II

TalentBurst, an Inc 5000 company; Norton (MA); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation

Medical, dental, vision

Retirement options

Job summary

TalentBurst is seeking an Analyst II for Quality Control Raw Materials in Norton, MA. The role focuses on testing, evaluating, and approving raw materials used in manufacturing to meet regulatory and internal specifications.

The position is onsite, with possible responsibilities at Cambridge, MA as needed. The candidate will document results, participate in qualification programs, and support audits and continuous improvement within the lab.

Qualifications

• Pharmaceutical/Biotech industry experience in a regulated lab setting or equivalent.
• B.S. in chemistry, biology, or biochemistry; related scientific field.
• Ability to work independently with attention to shifting priorities.
• Strong communication and teamwork skills.

Responsibilities

• Perform routine and non-routine inspection of raw materials.
• Maintain up-to-date training records and adhere to inspection schedules to support QC timelines.
• Document results in notebooks/LIMS and other controlled systems per GMP standards.
• Participate in raw material qualification programs, including vendor qualification and risk assessments.
• Collaborate with Manufacturing, Materials Management, and QA to ensure material availability and release timelines.
• Revise and update controlled documents to support continuous improvement and ALNY requirements.
• Support onsite audits and inspections as needed.

Skills

Attention to detail

Independent work

Communication

Teamwork

Education

B.S. in chemistry/biology/biochemistry

Associates Degree or Biotech Certificate considered

Tools

LIMS

Excel

Word

PowerPoint

Job description

Title: Analyst II, Quality Control Raw Materials

Location: Norton, MA

Duration: 12 Months

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.

Key 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.

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

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.