What are the responsibilities and job description for the Quality Control Analyst I/II position at Mariana Oncology?
Reporting:
Manager, Analytical Quality Control
Description:
We are seeking an experienced Quality Control Analyst I/II to join Mariana’s Analytical Quality Control function. You will be responsible for supporting the release and stability testing of our clinical therapies produced in our GMP manufacturing suite in Watertown. This person will play a role in creating and maintaining the highest standard of excellence for our therapies to treat cancer patients.
Illustrative Breadth of Responsibilities:
- Supports equipment qualification, method qualification and the quality testing of all radiopharmaceutical drug products for supporting Mariana’s clinical trial programs.
- Demonstrate initiative to perform routine QC responsibilities such as sample lifecycle, lab equipment maintenance, QC documentation, QC inventory control and reconciliation of sample requests/documents as needed.
- Supports the troubleshooting of problems associated with methods and instruments resolving them where possible or seeking additional guidance.
- Supports the revision of documentation such as SOPs and testing procedures.
- Adhering to all applicable procedures, cGLP, cGMPs, cGDPs, Mariana policies, QMS, and any other quality or regulatory requirements.
- Reviewing and analyzing analytical data to support lot release while closely working with Quality Assurance team.
- Recording, processing, compiling, and interpreting experimental data and results, and presentation of data in a cross-functional setting.
- Effectively manage workload with minimal supervision.
- Adhere to safe laboratory practices.
- Multi-task across several projects and manage time effectively to achieve results.
- Collaborate cross-functionally with clinical and CMC teams.
Requirements/Skills:
- Bachelor’s degree or Master’s degree in Biochemistry, Chemistry or related discipline with 0-2 years of experience working in a GMP quality control testing environment in the pharmaceutical or biotechnology industry. Experience working with radiopharmaceuticals will be considered as a plus.
- Working knowledge of cGMP regulations and ICH Guidelines.
- Commitment to maintain data integrity through strict adherence to standard operating procedures and policies.
- Good understanding of the radiation safety regulations and guidelines is preferred.
- Strong communication skills, with motivation to work effectively and cooperatively with others, and to establish and maintain good working relationships.
- Comfortable handling radioactivity and follow proper ALARA (As Low As Reasonably Achievable) technique
- Strong communication skills, with motivation to work effectively and cooperatively with others, and to establish and maintain good working relationships.
Mariana Oncology’s Principles
- Building a Legacy
- Execution Excellence
- Courage of our Convictions
