QC Analyst II

This role will be responsible for performing the routine QC testing following Standard Operating Procedures (SOPs) and established test methods. They will also perform various laboratory-based activities such as reagent preparation, tissue culture, equipment maintenance, sample receipt and disposal etc. The role involves getting involved in other tasks such as maintaining sample/reagent/consumable inventory and ordering reagents, updating forms and SOPs and writing as well are reviewing QC documents. This position is based in our Milton Park location and typically has a 5-day on-site expectation., The responsibilities of the QC Analyst II include, but are not limited, to the following:

• Perform QC testing of various samples according to Standard Operating Procedures (SOPs).
• Maintain various cell lines on regular basis by revival and passaging at set intervals.
• Review testing data and records of other operators and data verification for reports.
• Perform QC sample and material receipt and maintain inventory.
• Routine equipment maintenance and troubleshooting as required.
• Write or revise SOPs, protocols, FORMs and update as required.
• Participate in QC method transfers, qualification, and stability activities.
• Adhere to current Good Manufacturing Practices (cGMP) and Good Documentation practices (GDP).
• General lab tasks such as housekeeping, inventory of supplies, order supplies etc.
• Write deviations and CAPAs/ Change controls and assist with investigations and other documentation as required.
• Assist with internal and regulatory agency audits / inspections., 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 .
We are an Equal Opportunity Employer. #LI-Onsite


• Degree in Chemistry/Biochemistry/ other related science
Required Experience:
• 1-3 years of experience working in GMP/GLP environment or similar set up
• Competent analytical skills and attention for details.
• Understanding of GMP requirements preferred
• Computer literacy
• Ability to work independently and with others in a team.
  
  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.