QA Specialist I – Plant Ops

RoslinCT; Hopkinton (MA); Vor Ort; USD 65.000 - 90.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision insurance

401(k) plan

Educational assistance

Zusammenfassung

RoslinCT is seeking a QA Specialist I – Plant Operations to provide QA support for manufacturing operations and ensure compliance with cGMP/ICH. The role focuses on batch record creation and approval, documentation control, and improving QA processes to support product disposition and shipping.

Experience in cell therapy manufacturing is preferred. The ideal candidate will join a team dedicated to developing and manufacturing cutting-edge therapies, with a comprehensive benefits package

Qualifikationen

• 2–5 years of QA experience in pharma/biotech with internal manufacturing; Cell Therapy experience preferred.
• Experience in Quality Assurance Operations supporting internal manufacturing.
• Ability to partner cross-functionally and provide quality support within agreed timelines to support plant activities.
• Versed in cGMP and ICH regulations / guidelines.
• Strong verbal and written communication skills.

Aufgaben

• Create, review, and maintain batch records and labels.
• Review and approval of executed batch documentation.
• Review and approval of GMP documentation such as EM exceptions, Calibration/Work Order Records, equipment activation, and process-related forms.
• Monitor implementation of QA procedures for compliance and identify improvement opportunities.
• Support product disposition, packout, and shipping.

Kenntnisse

Quality Assurance

cGMP & ICH

Batch records review

Cell Therapy experience

Cross-functional collaboration

Jobbeschreibung

Who We Are

We at RoslinCT, are a world-leading cell and gene 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.

Who We Are

We at RoslinCT, are a world-leading cell and gene 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 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 QA Specialist I– Plant Operations is responsible for providing QA support and expertise to manufacturing plant operations. The ideal candidate also has experience with batch review and Lot Disposition, as well as Cell and Gene Therapy experience.

How You Will Make An Impact

• Create, Issue, and maintain batch records and labels.
• Review and approval of executed batch documentation
• Review and approval of GMP documentation such as, EM exceptions, Calibration/Work Order Records, equipment activation, various process-associated forms.
• Monitor implementation of QA specific procedures for compliance and identify opportunities for improvement
• Support product disposition, packout and shipping
• Provide QA review and approval of plant operations related procedures
• Promote quality culture among personnel

Minimum Qualifications

• Minimum 2-5 years of relevant Quality Assurance experience in a pharma/biotech company with internal manufacturing. Cell Therapy experience preferred.
• Prior experience in Quality Assurance Operations focused on support of internal manufacturing operations.
• Ability to partner cross functionally and provide quality support within agreed timelines to support plant activities
• Ability to work independently to meet objectives and timelines
• Ability to resolve issues and make decisions of low to moderate complexity independently and escape complex decisions as needed.
• Versed in cGMP and ICH regulations / guidelines
• Strong verbal and written communication skills

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.