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The Children's Hospital of Philadelphia Quality Control Analyst - Molecular Biology in Philadelphia, Pennsylvania

Reference #: 1007316 SHIFT:Day (United States of America)

Seeking Breakthrough Makers

Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation.

At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career.

CHOP's Commitment to Diversity, Equity, and Inclusion

CHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace. We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children.

We strongly encourage all candidates of diverse backgrounds and lived experiences to apply.

A Brief Overview The Clinical Vector Core (CVC) is a division of the Raymond G. Perelman Center for Cellular and Molecular Therapeutics (CCMT) at the Children's Hospital of Philadelphia. The CCMT fosters a multidisciplinary approach to develop cures for debilitating and life-threatening genetic disorders using innovative gene and cell therapy approaches.

CVC operations include manufacturing, quality control testing, and certification of recombinant adeno-associated and lentiviral viral vectors for use as Investigational Drugs in pre-clinical and early-phase clinical studies. CVC operations comply with FDA's current Good Manufacturing Practice regulations and other regulatory standards and guidelines applicable to early-phase Investigational Drugs. Vectors are made available to clinical programs in academia, industry and government in the U.S. and abroad.

This role I plays a vital role in the day-to-day operations of the Clinical Vector Core to assure the highest achievable quality and consistency of products, adherence to standards established in the CVC, and compliance with cGMP regulations. This role performs laboratory-based testing procedures (Q-PCR, ELISA, Western blot, etc.) and environmental monitoring of the facility. In addition, he/she performs and/or supports all aspects of test performance including pre-analytical, analytical and post-analytical phases of testing. This role participates in and assists with planning and coordination, reviewing of assay records, drafting of documents, and training and supervision of junior personnel commensurate with experience. This position requires specialized education in the biological or chemical sciences and is required to consistently exercise discretion and judgment in the execution and interpretation of experiments and of data derived.

All employees are responsible for compliance with written policies and procedures and for correctness, truthfulness, timeliness, legibility, integrity, and accuracy when recording data and observations in compliance with current cGMP regulations.Applicant must have a microbiology background with gene therapy , RT-PCR, qPCR, and dPCR experience.

What you will do Performs general lab duties Performs QC assays commensurate with training and experience Reviews basic QC assay records Performs environmental monitoring Reviews environmental monitoring records Drafts SOPs and work instructions Initiates change requests, incident reports and planned deviations Drafts investigations Develops new QC methods Trains and supervises junior personnel Performs other duties as assigned

Education Qualifications Bachelor's Degree Required Master's Degree Preferred

Experience Qualifications At least one (1) year quality control experience. Required At least three (3) years quality control experience Preferred At least three (3) years in cGMP/GLP (or other regulated) environment. Preferred

Skills and Abilities Demonstrated ability to prioritize work, strong organizational and documentation skills and initiative to improve processes. Change agent demeanor. Must be a flexible thinker, with an ability to quickly adapt to a rapidly changing environment. Team-oriented, self-starting individual with good communication skills.

To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must be fully vaccinated against COVID-19 and receive an annual influenza vaccine.

Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.

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Children's Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.

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