Senior Quality Control Specialist
2 weeks ago
The Advanced Regenerative Manufacturing Institute (ARMI) is a prominent non-profit organization dedicated to enhancing the bioeconomy of the United States. As part of its innovative initiatives, ARMI is leveraging cutting-edge automation and analytical methodologies to create scalable, consistent, and cost-efficient manufacturing processes for cells, tissues, and organs.
The Senior/Principal Quality Control Associate will play a crucial role in collaborating with various teams to design studies and conduct experiments aimed at refining manufacturing processes for biological products. This position emphasizes a strong commitment to cross-functional collaboration, ensuring responsiveness to the diverse needs of ARMI's ecosystem, including partnerships with engineering teams and the Deep Tissue Characterization Center.
Key Responsibilities:
- Engage in team-oriented process development to establish a quality control laboratory that meets phase-appropriate standards, including conducting process gap analyses and optimization.
- Oversee the organization, planning, and execution of experimental designs in collaboration with scientists to enhance quality control testing for flexible cell-based products.
- Assist in the creation and documentation of standard operating procedures and quality control methodologies.
- Collaborate with management and quality assurance to implement appropriate GMP processes within the laboratory.
- Participate in cross-training on various laboratory techniques to meet testing requirements.
- Utilize microbiological expertise to develop and execute microbiological testing methods.
- Summarize findings and present data during team meetings.
- Work collaboratively to achieve ARMI's strategic and technical goals.
- Maintain thorough and accurate documentation of laboratory activities.
- Contribute to the effective management of laboratory resources and equipment.
Qualifications:
- M.S. or B.S. degree with a minimum of 4 years of relevant experience in life sciences, particularly in microbiology, molecular biology, or biochemistry.
- Exceptional organizational skills and meticulous attention to detail.
- Proficient in executing complex culture protocols and managing multiple experiments simultaneously.
- Strong verbal and written communication skills, capable of addressing both scientific and non-scientific audiences.
- Excellent problem-solving and analytical abilities.
- Self-motivated with a willingness to learn and adapt quickly.
- Familiarity with microbiological techniques such as sterility testing, environmental monitoring, and growth promotion.
- Experience with GMP or GLP practices and detailed reporting.
- Background in quality control is preferred.
- Experience in process development and/or design of experiments (DOE) is advantageous.
- Knowledge of analytical techniques including real-time PCR, ELISA, flow cytometry, mechanical testing, histology, and immunostaining is preferred.
- Experience in technology transfer is a plus.
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