What are the responsibilities and job description for the Sr. Associate, 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.
Join us, as we reshape the future.
Job Summary:
This Senior Associate PQA position is the primary QA resource during manufacturing production activities, providing real time quality oversight for Drug Substance, Drug Product, and all other production and QC testing activities. This position will be required to proactively support cGMP compliance and interact with all departments within the company.
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 maintaining compliance with cGMP standards and keeping the plant in compliance with corporate quality requirements.
- Perform Quality walkthroughs and inspections on the floor, to maintain inspection readiness environment.
- Review and approve deviations, CAPAs, and change controls.
- Review and approve executed production batch records, logbooks, data, and Certificates of Analyses.
- Perform verification of data to assist with 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.
- Conduct training on procedures, standard work, safety, and cGMP related topics.
- Assist internal and external audits and regulatory inspections.
Other responsibilities:
- Proactively support cGMP compliance in the business by reporting on KPI performance.
- Assist with the implementation and continuous improvement of the Quality System.
- Support Clinical QA activities as needed.
- Assist with vendor qualification or evaluation/inspection.
- Lead and participate in continuous improvements projects.
- Other duties, as assigned.
Qualifications
Education:
- Bachelor’s degree in science preferred.
Required Experience:
- 3-5 years of quality or mix of quality/manufacturing experience in biotech or pharmaceutical industry.
- High level of attention to detail and excellent time management.
- A very organised and methodical approach to tasks.
- Strong written and verbal communication skills to interact with other functions.
- Strong collaboration skills
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.
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