QC Analyst II, Flow Cytometry & Molecular Biology

RoslinCT; Hopkinton (MA); Vor Ort; USD 75.000 - 105.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision insurance

Educational assistance

401(k) program

Career development resources

Zusammenfassung

RoslinCT in Hopkinton, MA is seeking a QC Analyst II, Flow Cytometry & Molecular Biology to execute analytical method transfers to Quality Control, optimize assays, and author SOPs and Test Methods.

You will work with cGMP systems, review data, support method transfers, calibrate equipment, and train analysts while collaborating across teams to improve quality and efficiency.

Qualifikationen

• Bachelor's degree in a scientific discipline
• 3–5 years of cGMP QC laboratory experience
• Hands-on experience with flow cytometry, qPCR, dPCR, ELISAs, and cell-based assays
• Knowledge of cGMP/ICH/FDA regulations
• Strong troubleshooting and documentation skills

Aufgaben

• Perform routine and non-routine quality control testing on in-process samples and finished products.
• Operate and maintain laboratory equipment and instruments, ensuring proper calibration and adherence to cGMP.
• Provide support for method feasibility/transfers/qualification/validation and stability testing.
• Support analytical equipment installation and qualification.
• Review data in accordance with procedures and cGMP requirements.
• Author, review, and/or approve Protocols, SOPs, Test Methods, and related QC documents.
• Participate in internal and external audits, inspections, investigations, change controls, and CAPAs.
• Contribute to continuous improvement initiatives for efficiency gains in QC.
• Communicate effectively with management about task progress and blockers.
• Train analysts on assigned assays and document training per cGMP.
• Provide support to QC Analyst SME in Flow Cytometry.
• Work independently in a fast-paced team environment and meet deadlines.

Kenntnisse

Flow cytometry

qPCR

dPCR

ELISAs

Cell-based assays

MS Office

Ausbildung

Bachelor's degree in scientific discipline

Tools

MS Office

Jobbeschreibung

Who We Are

We are a 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. We work both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

Who We Are

We are a 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. We work both autonomously and in driven teams to make life-changing products utilizing ground-breaking science.

THE ROSLINCT WAY

Here at RoslinCT, our team contributes to the development 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 QC Analyst II, Flow Cytometry & Molecular Biology, will be executing analytical method transfers to Quality Control, optimize and troubleshoot assays for improvement. He/she will be responsible for authoring Protocols, Standard Operating Procedure (SOP’s) and Test Methods. He/she will be executing various quality control methods, analyzing data, and reporting data. He/She will be executing various quality control 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. This position is highly visible in the organization and requires the ability to interface with multiple groups, and the ability to assess method suitability, interpret results, perform tasks independently, and troubleshoot.

How You Will Make An Impact

• Perform routine and non-routine quality control testing on in-process samples and finished products.
• Operate and maintain laboratory equipment and instruments, ensuring proper calibration and adherence to cGMP Compliance.
• Provide support for method feasibility/transfers/qualification/validation and stability testing.
• Support analytical equipment installation and qualification
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
• Review all data in accordance with applicable procedures and cGMP requirements.
• Author, review, and/or approve Protocols, SOPs, Test Methods, and other procedures required to operate a QC laboratory.
• Participate in internal and external audits, inspections, investigations, change controls and CAPAs
• Contribute to continuous improvement initiatives, identifying opportunities for efficiency gains and process optimization within the quality control function.
• Anticipate and troubleshoot problems. Communicate effectively with management regarding task completion, roadblocks, and needs.
• Become a qualified trainer on assigned assays and deliver training to analysts, documenting training per procedural and cGMP requirements.
• Provide support to QC Analytical Subject Matter Expert in Flow Cytometry.
• 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.

What You Will Bring

• Bachelor's Degree in scientific discipline.
• 3 – 5 years of relevant experience in cGMP Quality Control Laboratory.
• Hands-on experience with various analytical techniques such as flow cytometry, qPCR, dPCR, ELISAs, cell-based assays, and scientific knowledge in the characterization and transfer of analytical methods.
• Experience with rapid microbiological methods is a plus (e.g. mycoplasma)
• 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.
• Strong troubleshooting, problem-solving skills, oral and written skills.
• Ability to multi-task and interact with multiple groups in a team-oriented environment.

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.