QC Raw Materials Analyst II

Planet Pharma; Norton (MA); On-site; USD 79,000 - 87,000; Full time

Job summary

Planet Pharma is seeking a QC-RM/SM Analyst II to support testing, evaluation, and release of raw materials for manufacturing. The role emphasizes GMP-compliant documentation, timely testing, and collaboration with QA and Manufacturing in Norton, MA with possible duties in Cambridge, MA.

Ideal candidates will have a BS in chemistry/biochemistry or related field and 3–6 years of regulated lab experience, with strong data recording and cross-functional communication skills.

Qualifications

• Bachelor or higher in chemistry, biology, biochemistry, or related field.
• 3–6 years in a regulated lab setting, QC or equivalent.
• Ability to work independently with shifting priorities.

Responsibilities

• Inspect raw materials routinely and non-routinely.
• Maintain training records and adhere to inspection schedules.
• Document results in notebooks/LIMS per GMP standards.
• Participate in material qualification and supplier qualification.
• Collaborate with Manufacturing, Materials Management and QA.
• Contribute to controlled documents and SOPs updates.

Skills

Communication

Teamwork

Attention to detail

Education

B.S. in chemistry/biology/biochemistry

Associates Degree or Biotech Certificate

Tools

LIMS

Excel

Word

PowerPoint

Job description

Overview

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 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

Pay ranges between 38-42hr based on experience