QA Sterility Assurance - Sterility Assurance Specialist I

Minaris Advanced Therapies•Philadelphia, PA

1d•Onsite

About The Position

Be part of something bigger at Minaris Advanced Therapies—where every role contributes to creating hope for patients around the world. As a global leader in cell and gene therapy development, manufacturing, and testing, we turn breakthrough science into real-world treatments that change lives. Our team of over 1,000 experts across North America, Europe, and Asia has helped bring transformative therapies to market. At Minaris, you’ll join a purpose-driven community focused on innovation, collaboration, and patient impact. Whether you’re in the lab, in the cleanroom, or behind the scenes, your work will directly support life-saving therapies and make a lasting difference. If you're passionate about advancing cutting-edge science and believe in the potential of cell and gene therapies, we invite you to help shape the future of medicine—one patient at a time. Position Summary Responsible for producing documents for sterility assurance related programs, providing aseptic processing oversight, and technical support to manufacturing operations to ensure contamination control. Acts as the Primary Sterility Assurance Representative and effectively collaborates with multi-disciplinary teams for designated projects.

Requirements

Knowledge of GLP and cGMP guidelines is required.
Ability to make decisions based on a wide knowledge of factors where application of advanced or technical concepts is predominantly required.
Ability to evaluate technical data and write technical documents.
Ability to use judgment as dictated by complexity of situation.
Ability to work under limited supervision and to handle problems of a difficult nature.
Ability to accomplish the duties described through the use of appropriate equipment and software.
Ability to accurately and reproducibly perform arithmetic calculations including fractions, decimals and percentages and basic algebraic and geometric calculations.
Ability to record data accurately and legibly.
Ability to understand and follow verbal or demonstrated instructions.
Proficient in Oral & Written communication skills
Need to be able to read, write and understand English
Proficient in Microsoft (Excel, Word, Outlook)
Bachelor’s degree with a major in Biology, Microbiology or related Life Science
3-5 years relevant technical experience
Ensure compliance with all FDA and Worldwide Quality & Compliance regulations in all aspects of your work.
Adhere to established procedures and protocols, prioritize continuous training and skill development, and uphold the highest standards of data integrity to ensure accuracy, compliance, and operational excellence.

Responsibilities

Authors and reviews qualifications such as environmental monitoring performance qualification (EMPQs), aseptic process validations (APVs), and airflow visualization (smoke studies).
Owns change control tasks associated with qualification or program revisions
Authors risk assessments in support of microbial control strategy and sterility assurance programs
Performs aseptic processing training for manufacturing and support personnel
Participates in continuous improvement and implementing best practices (ensuring understanding/ compliance with SA related regulations and guidance
Performs regular GEMBA style assessments of the aseptic process on site to assess compliance of operations including identification of deficiencies and provide real time coaching to aseptic staff
Authors new and revised procedures for Sterility Assurance department.
Data approval in EMDS system
Coordinates with Project teams in design, set up and execution of projects
Maintains current regulatory knowledge, staying up to date with best practices and sharing knowledge
Participates in business excellence projects within SA and across site
Ability to work in a team environment and independently as required
Contributes to the overall operations and to the achievement of departmental goals
Perform job specific tasks in compliance with applicable Regulations, International Standards, and Minaris Advanced Therapies Policies and Standard Operating Procedures.
Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices
Other duties as assigned
May be required to assist in other departments