Quality Control Administrative Coordinator, Radiopharmaceutical Contract Manufacturing

Job Description: Quality Control Administrative Coordinator, Radiopharmaceutical Contract Manufacturing, NJ5 Title Quality Control Administrative Coordinator Location NJ5-Totowa, New Jersey Department Radiopharmaceutical Contract Manufacturing Training Curriculum ID TCU.010 Overview: The Quality Control Administrative Coordinator (RCM) will be responsible for providing administrative support for the Quality Control, Environmental and Microbiology Laboratory program, including supporting the use of the Laboratory Management System at the site level. This role might also include supporting scientists in the performance of product testing or facility monitoring. Essential Duties and Responsibilities ▪ Assist site Laboratory leadership and laboratory team to maintain the Quality Control, Environmental and Microbiology program and Laboratory Management System (LMS) at the SOFIE NJ5 facility, that produces finished drug products under both 21 CFR Part 211 and EudraLex Volume 4 regulations, by performing the following: ▪ Accurately and expeditiously request controlled, executable GMP documents from QA for site laboratory and support staff. These documents may be associated with validations, development and finished product manufacturing, raw material release, environmental monitoring, metrology, or other site programs. ▪ Establish and maintain control of issued and executed documents across the QC group to ensure compliance with standard operating procedures and filings. Generally, maintain awareness of location of all laboratory documents within the facility. ▪ Monitor materials and supply inventory to ensure that the Laboratory Material Management Program functions effectively, specifically by timely tracking and ordering of required lab supplies, reagents, chemicals, etc., with effective coordination and collaboration with the site procurement team and other stakeholders/client project teams. ▪ Assist in preparation of reagents and test solutions for analytical methods according to standard operating procedures and written instructions. ▪ Assigned, assist with material acceptance processes. ▪ Assist with laboratory instrument management program in cooperation with facility engineering and metrology to complete and route necessary documentation for Quality Assurance review, always Maintaining GMP readiness. ▪ Assist with logistics and documentation associated with disposal of QC and microbiology waste (common, biologic, hazardous, and radioactive) in accordance with SOPs and regulatory requirements. Assist Radiation Safety Officer and EHS team to maintain documentation of laboratory safety programs. ▪ Assist with logistics and documentation of QC and microbiology samples for external testing, including raw material, finished product and environmental isolate samples. ▪ Track, log and ensure closure of executable documents and laboratory notebooks. Organize and manage the documentation in the QC laboratory when not in use. Manage laboratory logbooks and ensure completeness and reconciliation. Assist reviewing general purpose and critical equipment logbooks as assigned. ▪ As directed, assist with closing of laboratory documents with site QA, including document reconciliation. As directed, sort, organize and scan approved finished product records saving in secure databases. May include migrating documents to share sites with product sponsors. ▪ Assist with organization of the Document Control Room. Assist with migration of documents to external storage sites. As needed, convert hardcopy laboratory QMS documents for electronic archival, or sharing with sponsors. ▪ As assigned, assist with organization of completed training records and administration of training. ▪ During regulatory, external and internal audits, assist with the organization and delivery of requested documents. ▪ Independently, or working with other site administrative professionals, facilitate room reservation, catering, communication and other customer (internal or external) support to help ensure positive experience of visitors to the NJ5 facility. ▪ Assist with preparation of laboratory metrics and associated presentations including, Quarterly Management Review slide decks or other QC presentations as directed. ▪ Apply quality control processes and procedures in all job tasks to ensure product quality and regulatory compliance.▪ Comply with all applicable standard operating procedures and regulations, including 21 CFR Part 211 and EudraLex Volume 4 requirements. ▪ Maintain a clean and safe working environment and perform radiation safety duties in compliance with safety and pharmaceutical regulations. Work collaboratively with other laboratory technicians and EM technicians. ▪ Assist QC Chemists, Microbiologists and perform other duties as assigned by Senior Scientist / Lead and Laboratory Supervisory / Management. Qualifications ▪ HS Degree in a related field with 2+ years of experience or AS Degree in Quality Control or Material management and Document Control function in an FDA regulated environment preferred (or equivalent combination of education and experience). ▪ Experience in pharmaceutical operations is preferred but not required ▪ Knowledge of USP, FDA, and cGMP regulations preferred. ▪ Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedures required. ▪ Ability to write reports, business correspondence, and other business and quality assurance documents required. ▪ Strong organizational skills are required. ▪ Ability to solve problems and handle issues required ▪ Ability to work collaboratively across all departments at site level. ▪ Proficiency in MS Office applications required. ▪ Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external partners required. ▪ Knowledge of Lean Six Sigma methodologies or 5S organization skills is desired.