Senior Quality Assurance Specialist

Job Type:Location: LOC_COLKET-Colket Translational ResearchReq ID: 83533Shift: DaysEmployment Status: Regular - Full Time Job SummaryThe 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 participates in the day-to-day operations of the Clinical Vector Core facility, with a primary responsibility to perform complex QA and Document Control functions in support of the viral vector manufacturing process under current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP), including record review, reviewing policies and procedures, assisting in planning, processing and investigating incidents and deviations, planning and corrective and preventative actions and change control, batch production record review, reviewing QC test records and raw data, and may perform subject matter expert functions, as assigned and commensurate with experience, as described under job responsibilities.
This team member plays a vital role in the CVC and helps assure that non-clinical and clinical grade viral vector manufacturing complies with cGMP standards.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

• Performs routine QA functions including but not limited to material control, shipping and tracking of drug products and biological materials
• Performs technical review of records for clarity, correctness, and compliance with relevant SOPs
• Drafts policies and procedures
• Reviews policies and procedure
• Assist in planning, processing and investigating deviations
• Initiates incident reports and planned deviations
• Reviews incident reports and planned deviations
• Plans and participates in corrective and preventative actions and change implementation
• Reviews batch production records
• Reviews QC test records and raw data
• Participates in hosting client and regulatory audits
• May perform subject matter expert functions as assigned commensurate with experience
• Performs other duties as assigned
  

Job Responsibilities (Continued)Job Responsibilities (Continued)Required Licenses, Certifications, RegistrationsRequired Education and ExperienceRequired Education: Bachelor’s degree
Required Experience:

• Three (3) years of quality assurance experience.

Preferred Education, Experience & Cert/LicPreferred Education: Master’s degree in pharmaceutical, biological or chemical sciences
Preferred Experience:

• Five (5) years of quality assurance experience.
• Five (5) years of experience in a GMP/GLP manufacturing environment or other regulated environment.

Preferred Licenses/certificates/registrations:

• Current Good Manufacturing Practices (cGMP) certification or within 180 days of placement into position.

Additional Technical Requirements

• 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.
  

All CHOP employees who work in a patient building or who provide patient care are required to receive an annual influenza vaccine unless they are granted a medical or religious exemption.Children's Hospital of Philadelphia is committed to providing a safe and healthy environment for its patients, family members, visitors and employees. In an effort to achieve this goal, employment at Children's Hospital of Philadelphia, other than for positions with regularly scheduled hours in New Jersey, is contingent upon an attestation that the job applicant does not use tobacco products.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.VEVRAA Federal Contractor/Seeking priority referrals for protected veterans. Please contact our hiring official with any referrals or questions.CHOP Careers ContactTalent Acquisition2716 South Street, 6th FloorPhiladelphia, PA 19146