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Quality Assurance Specialist in Operations Strategy
2 months ago
Salary: Competitive
Company Overview:
Iovance Biotherapeutics is a pioneering organization dedicated to the advancement and commercialization of innovative cancer immunotherapies. We are currently seeking a Quality Control Specialist focused on Operations Strategy to enhance the long-term viability of our Lean Labs initiative within the Quality Control Department.
Role Summary:
The Quality Control Specialist will play a pivotal role in fostering continuous improvement across various QC functional areas. This position will involve the development and upkeep of QC workforce models to ensure alignment with patient demand. Additionally, the Specialist will contribute to strategic planning for the implementation of pipeline products and projects within the QC department.
Key Responsibilities:
- Work collaboratively with the Senior Manager of Quality Control, Operations Strategy, and other QC functions to strategically plan future initiatives, including new product introductions and laboratory capacity planning.
- Develop and maintain planning tools to facilitate growth within the quality control organization, including headcount capacity models.
- Support the deployment and ongoing management of Lean Labs implementation within Quality Control.
- Maintain and update QC workforce models to reflect current needs.
- Regularly assess KPIs, metrics, and performance indicators to evaluate the effectiveness of quality functional areas.
- Assist in enhancing QC's lean capabilities through training and coaching in problem-solving methodologies.
- Collaborate with continuous improvement professionals to address business needs and drive effective solutions.
- Adhere to Iovance Biotherapeutics' core values and compliance standards.
- Ensure compliance with safety protocols and laboratory procedures.
- Perform additional duties as assigned.
Qualifications:
- Bachelor's degree in a relevant field (biological sciences or equivalent).
- Minimum of three years of experience in the biopharmaceutical industry, particularly in a cGMP Quality Control role.
- Familiarity with operational excellence concepts, including lean methodologies and tier governance.
- Strong understanding of Quality Control practices, including microbiology and analytical testing.
- Proficient in MS Office applications (Word, Excel, PowerPoint, Visio).
- Ability to work effectively within multi-disciplinary teams.
- Detail-oriented with excellent communication skills.
- Proven ability to manage multiple priorities and meet deadlines.
- Demonstrated strategic planning and implementation skills.
- Adaptable and eager to tackle challenges.
- Proactive problem solver.
Preferred Qualifications:
- Experience with cell therapy products is advantageous.
Physical and Mental Demands:
- Ability to sit for extended periods while working on a computer.
- Strong analytical and problem-solving skills, with the capacity to manage work-related stress and multiple priorities.
Work Environment:
- This role involves working in an office setting with occasional visits to Quality Control labs.
- Must be able to work in a laboratory environment with potential exposure to various chemicals and biohazards.
Iovance is committed to fostering a diverse and inclusive workplace. We are an equal opportunity employer and value all individuals regardless of their background.