What are the responsibilities and job description for the Operations Quality Specialist position at Children's Hospital of Philadelphia?
Location: LOC_COLKET-Colket Translational Research
Req ID: 201532
Shift: Days
Employment Status: Regular - Full Time
About Us
We’re seeking breakthrough makers! Children’s Hospital of Philadelphia was built on the belief that we can change lives. Today, in every role throughout our hospital, research institute and care network, the 22,000 members of our workforce are finding new ways – big and small – to make a difference for the patients and families we serve.
We’re seeking breakthrough makers! Children’s Hospital of Philadelphia was built on the belief that we can change lives. Today, in every role throughout our hospital, research institute and care network, the 22,000 members of our workforce are finding new ways – big and small – to make a difference for the patients and families we serve.
If you are ready to challenge yourself, be inspired and grow – no matter what your role – you just may be the kind of breakthrough maker who will thrive at CHOP.
CHOP is proud to share that we are ranked No. 1 on Forbes' 2022 list of America's Best Large Employers!
Job Summary
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.
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This role plays a vital role in supporting 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 is responsible for providing compliance support to the Operations Unit and to ensure that processes are continuously improved in accordance with current Good Manufacturing Practices (cGMP).
This position is contained within the Operations Unit and works closely with all CVC departments as well as outside vendors to resolve issues in a timely and often innovative manner to minimize downtime.
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.
Job Responsibilities
- Supports efforts to minimize downtime by progressing and performing nonconformance investigations, final review of time sensitive equipment/facility deviations, and out-of-specification reports initiated by the Operations department and other departments as needed.
- Works closely with Quality Assurance and in collaborations with all CVC departments to develop process improvements in response to equipment/facility deviation and out-of-specification reports.
- Responsible for initiation and implementation of Operations related process improvements such as Corrective and Preventive Actions (CAPA), initiating Change Requests, and revising Standard Operating Procedures (SOP).
- Responsible for initiating time sensitive Planned Deviation Reports (PDR) and ensuring necessary approvals on behalf of Operations department.
- Responsible for maintaining organized equipment records.
- Assist in training as needed in response to nonconformities or major procedure changes.
- Trains junior personnel
- Expected to communicate proactively with management, highlighting issues and proposing solutions and performs other duties as assigned.
Job Responsibilities (Continued)
Job Responsibilities (Continued)
Required Licenses, Certifications, Registrations
Required Education and Experience
Required Education: Bachelor’s degree
Required Experience: Three (3) years of facilities, equipment, quality or operations experience
Preferred Education, Experience & Cert/Lic
Preferred Education: Master’s degree
Preferred Experience:
- Five (5) years of facilities, equipment, quality or operations experience
- Three (3) years of relevant experience in cGMP/GLP (or other regulated) environment.
Additional Technical Requirements
- Intermediate knowledge of current Good Manufacturing Practice (cGMP) regulations
- 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
- Strong verbal and written communications skills
To carry out its mission, it is of critical importance for the Children’s Hospital of Philadelphia (CHOP) to keep our patients, families and workforce safe and healthy and to support the health of our global community. In keeping with this, CHOP has mandated all workforce members on site at any CHOP location for any portion of their time be vaccinated for COVID-19 as a condition of employment. This mandate also applies to workforce members performing work for CHOP at non-CHOP locations. Additionally, all workforce members based in or regularly scheduled to work at any New Jersey location are mandated to be both vaccinated and boosted for COVID-19, with booster timing consistent with applicable guidelines. The CHOP COVID-19 vaccine mandate is in alignment with applicable local, state and federal mandates. CHOP also requires all workforce members who work in patient care buildings or who provide patient care to receive an annual influenza vaccine. Employees may request exemption consideration for CHOP vaccine requirements for valid religious and medical reasons. Please note start dates may be delayed until candidates are fully immunized or valid exemption requests are reviewed. In addition, candidates other than those in positions with regularly scheduled hours in New Jersey, must attest to not using tobacco products.
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