What are the responsibilities and job description for the Associate II, Plant Quality Assurance position at Replimune, Inc.?
Overview
Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because patient’s lives depend on it. We imagine a world where cancer is a curable disease.
At Replimune, we live by our values:
United: We Collaborate for a Common Goal.
Audacious: We Are Bold and Innovative.
Dedicated: We Give Our Full Commitment.
Candid: We Are Honest With Each Other.
People are at the center of everything we do, and when it comes to our employees, we make it personal. With a deep sense of purpose, an innovative and collaborative culture, a competitive and forward-looking total rewards program, everyone at Replimune has a unique opportunity to contribute to the meaningful work we do which could impact the lives of patients, caregivers and themselves.
Join us, as we reshape the future.
Job Summary:
This PQA II position serves as primary QA resource during manufacturing production, providing real time quality oversight. This position will be required to interact with all departments within the company and to proactively support cGMP compliance.
- This position is based in our Framingham location and typically has a 5-day on-site expectation.
Responsibilities
Key responsibilities:
- Ensure quality and regulatory compliance during on-the-floor processing.
- Work alongside manufacturing teams to ensure current and best practices are implemented consistently.
- Perform Quality walkthroughs and inspections on the floor, to maintain inspection readiness environment.
- Support as QA contact to review and approve deviations, CAPAs, and change controls.
- Review and/or approve executed production batch records, logbooks, data, and certificates of analyses.
- Assist batch disposition process.
- Review and approve quality documents from Manufacturing, QC, Facilities & Engineering, Validation and PD, such as: SOPs, batch records, logs, training forms, protocols, plans, summary reports, risk assessments, work orders, etc.
- Assist internal and external audits and inspections.
Other responsibilities:
- Assist QS activities as needed.
- Support Clinical QA activities as needed.
- Assist vendor qualification or inspection.
- Participate in continuous improvements projects
- Other duties, as assigned.
Qualifications
Education:
- Bachelor’s degree in science preferred.
Required Experience:
- 2-4 years of quality and/or manufacturing experience in biotech or pharmaceutical industry.
- High level of attention to details and excellent time management.
- A very organised and methodical approach to tasks.
- Strong written and verbal communication skills to interact with other functions.
- A level of flexibility is essential to meet varying workloads.
About Replimune Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of a novel portfolio of oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.
We are an Equal Opportunity Employer.
