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Quality Assurance Associate II/III - Operations

Company: Paragon Gene Therapy, a unit of Catalent Biologics
Location: Harmans
Posted on: October 20, 2019

Job Description:

Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses. Quality Associate I or II (QA Operations) is responsible to provide Quality Assurance support real-time for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA on the Floor oversight of manufacturing including observing critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products. This position will work either 2nd or 3rd shift. Key Responsibilities include, but are not limited to: Performs QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing. Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices Review executed Manufacturing Batch Records and supporting documentation for completeness, accuracy and compliance. Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product. Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions. Participates in root cause analysis using methodologies, such as: fishbone, 5 whys, comparative analysis, etc. Act as QA reviewer for deviations and CAPA issuance; with limited approval authority as designated by QA Management. Also perform Acceptable Quality Limit (AQL) visual inspection of drug product Participate in SOP revision as it pertains to process improvements. Participate in site quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary. Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices. Education & Experience: Bachelor Degree in engineering or science field preferred; HS Diploma with requisite number of experience to equal a degree in addition to the below will be considered. QA Associate I - 1 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry with experience in GmP Manufacturing or QA on the floor QA Associate II - 3 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical industry with experience in Quality Assurance function with on the floor responsibilities. Some of this experience can be in a manufacturing role We will consider experience as a substitute for higher education. A High School Diploma/GED is a basic requirement in these situations. Familiarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH Guidelines Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks Exposure to Lean Operational Excellence highly desirable Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. #LI-EW1

Keywords: Paragon Gene Therapy, a unit of Catalent Biologics, Severn , Quality Assurance Associate II/III - Operations, Other , Harmans, Maryland

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