QC Analyst I, Analytical

RoslinCT US; Hopkinton (MA); On-site; USD 55,000 - 75,000; Full time

Job summary

RoslinCT US is seeking a Quality Control Raw Material Analyst to perform QC inspection and sampling of incoming materials, author specifications, and conduct routine cGMP testing. The role supports technology transfer and method qualification, while ensuring compliance with quality systems and regulatory requirements.

The candidate will work with analytical teams, document SOPs, and participate in audits, investigations, and CAPAs.

Qualifications

• Bachelor's degree in a scientific discipline is required.
• 0-2+ years of relevant raw material QC lab experience in a cGMP setting.
• Knowledge of cGMP/ICH/FDA regulations.
• Ability to independently prioritize and manage multiple projects and timelines.
• Experience with MS Office and LIMS for documentation and data management.
• Strong troubleshooting and communication skills, both written and oral.

Responsibilities

• Perform QC inspection and sampling of incoming raw materials and packaging components.
• Author material specifications or SOPs to support Raw Material Program.
• Perform routine and non-routine QC testing on raw materials, in-process samples, and finished products.
• Ensure calibration and maintenance of laboratory equipment; support 21 CFR Part 11 compliance.
• Collaborate with cross-functional teams and participate in internal/external audits and CAPAs.

Skills

Prioritization

Troubleshooting

Communication

Teamwork

Education

Bachelor's degree in scientific discipline

Tools

LIMS

MS Office

Job description

WHO WE ARE

RoslinCT is a world-leading cell therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

THE ROSLINCT WAY

Here at RoslinCT, our team can contribute to the development and delivery of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

ACCELERATING YOUR FUTURE

The Quality Control Raw Material Analyst will be responsible for QC inspection and sampling of incoming raw materials, author and revise material specifications, perform routine and non-routine QC testing on raw materials, in-process samples and finished products in support of cGMP manufacturing including pH, Osmolality, appearance, visual inspection, cell counting and related methods. This position will also provide support to assist the QC group and partner project teams during technology transfer, analytical method qualification, and routine GMP testing.

The QC Analyst I, Analytical will partner with the analytical team, interface with multiple groups, and must have the ability to assess method suitability, interpret results, perform tasks independently, and troubleshoot.

He/she will be responsible for authoring Standard Operating Procedures (SOPs), specifications and Test Methods. He/she will assist in the implementation of new assay methodologies and the associated instrumentation.

Identifies and supports initiation and completion of deviations, corrective and preventative actions, and laboratory investigations in compliance with all applicable quality systems and current cGMPs.

HOW YOU WILL MAKE AN IMPACT

• Perform QC Inspection and sampling (as needed) on all incoming raw materials and packaging components following detailed written procedures
• Author material specification documents or SOP’s or other procedures (as needed) to support the site Raw Material Program
• Perform material inspections via an electronic system
• Assist in preparing and sampling raw materials for shipment to external testing laboratories
• Possess the ability to evaluate certificate of analysis of chemicals/raw materials/packaging components
• Perform routine and non-routine QC testing on raw materials, in-process samples and finished products in support of cGMP manufacturing of cell therapy products, as needed
• Operate and maintain laboratory equipment and instruments, ensuring proper calibration and adherence to cGMP Compliance
• Support analytical equipment installation and qualification, ensuring 21 CFR Part 11 compliance
• Work collaboratively with cross functional departments, as needed
• Adhere to compliance of Warehouse area in terms of Isolation of Quarantine and Released materials
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner
• Participate in internal and external audits, inspections, investigations, change controls and CAPAs, as needed
• Work independently in a high-paced team environment, meet deadlines, and prioritize work from multiple projects
• Communicate effectively with cross-functional peers, and department management regarding task completion, roadblocks, and needs
• Other duties as assigned by management

WHAT YOU WILL BRING

• Bachelor's Degree in scientific discipline
• 0-2+ years of relevant raw material experience in cGMP QC Laboratory, or equivalent (raw material testing is a plus)
• Knowledge in ANSI.ASQ Zl.4 sampling plans (desired)
• Hands-on experience with various analytical techniques such as pH, osmolality, identifications, ELISAs, cell-based assays (desired)
• Knowledge of cGMP/ICH/FDA regulations
• Ability to independently prioritize/manage activities
• Ability to prioritize objectives from multiple projects and adhere to scheduled timelines while maintaining flexibility and attention to detail
• Proficient in MS Office applications and information technologies that support documentation and data management systems. Experience in LIMS.
• Strong troubleshooting, problem-solving skills, oral and written skills
• Experience working in a team environment and communicating effectively

WORKING CONDITIONS

• Monday-Friday, 1st Shift (e.g., 8am-5pm)
• Flexible work schedule – Some nights, weekends and holidays will be required on occasion in support of 24/7 manufacturing operations.
• Job will require ability to lift up to 25 pounds, stand for extended periods of time, and complete repetitive tasks.

Final compensation will be based on a variety of factors, including education, experience, technical expertise, specialized skill sets, market demand, internal equity, and business needs.

At RoslinCT, we offer more than just competitive pay. Our comprehensive Total Rewards package is designed to support your health, financial well-being, and professional development throughout your career. Benefits include medical, dental, and vision insurance, educational assistance, a 401(k) program, and a variety of additional resources to help you thrive both personally and professionally.

OUR COMMITMENT

All RoslinCT employees embrace the principles of our culture and values and are deeply committed to fostering an environment where diversity and inclusion are not only valued but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways.

RoslinCT is proud to be an equal opportunity employer, we seek to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or any other applicable legally protected characteristics.