Quality Assurance - Associate
Ingenus Denville, NJ
- Expired: over a month ago. Applications are no longer accepted.
Overview of Position:
All stages of pharmaceutical industry operations are closely regulated and monitored by bodies such as the US Food & Drug Administration (FDA), Drug Enforcement Agency (DEA), Environmental Health and Safety (EHS) and others. In addition, there are many different guidelines which are required to be followed to maintain compliance with the aforementioned regulatory bodies, such as, the Code of Federal Regulations (CFR), International Council for Harmonization (ICH), World Health Organizations (WHO), International Standards Organization (ISO), Pharmaceutical Inspection Convention (PIC), Medicines and Healthcare Products Regulatory Agency (MHRA) and others. These regulatory guidelines provide the structure for good manufacturing practices.
If drug product is not made safely and correctly it will impact a patient’s life who is taking this medicine. The Quality Assurance group, with support from the Quality Assurance Associate, ensures that all operations related to manufacturing, processing, packing, and testing conform with current good manufacturing practices to assure that such drug meets the requirements of safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess.
The Quality Assurance Associate, under the supervision of the Manager of Quality Assurance, works closely with other Quality Assurance personnel, Quality Control, Formulation, Analytical Research and Development, Contract Manufacturers, Vendors and others to review and approve documentation related to product quality.
Job Duties and Responsibilities:
· Maintain tracking of global Quality processes/functions in coordination with site Quality management
· Oversee Vendor Qualification program, including but not limited to maintenance of qualified vendor list, scheduling of on-site, virtual and self-inspections
· Preparation and management of Quality Agreements
· Review and approve specifications, standard test procedures, and protocols/reports
· Review, approve and release certificates of analysis following confirmation of conformance of testing to validated procedures and approved specifications
· Review and approve data in LIMS
· Conduct training and provide guidance related to adherence to current good manufacturing practices and current good documentation practices
· Support all site regulatory inspections and customer audits including maintaining site readiness of essential documentation
· Participate in quality functions related to management of stability studies for both R&D and commercial projects
· Conduct internal audits, identify CAPAs, and oversee effectiveness of CAPA implementation to maintain site quality compliance
· Assignment of instrument identifications and review of qualifications and calibrations
· Issuance and archival of notebooks
· Maintenance of raw data and original documents as per approved site procedures
· Document control activities including making documents effective, obsoleting old version, issuance and tracking of controlled copies
· Management of site standard operating procedures (SOPs) including archival and control of master documents, tracking and notification related to biennial review requirements, tracking and notification to essential personnel of training requirements related to each procedure
· Creation of logbooks associated with SOP annexures
· Maintenance of site and individual training records and ensuring training fulfillment based upon approved training matrices
· Management of electronic documentation archival/storage
· Organization of and maintenance of secure document archival cell
· Initiate, review and approve site SOPs followed by enforcement of approved procedures
· Initiate, review and approve Change Controls followed by tracking of action items to facilitate closure
· Monitoring of site quality metrics and preparation of biweekly reports to site and corporate quality management
· Tracking and trending of investigations, change controls, documentation practices, etc.
· Other duties as assigned by the Manager
· Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, Regulatory Affairs or related field with 2+ years of experience in a cGMP regulated environment, or:
· Master’s degree in Pharmaceutical Sciences, Life Sciences, Regulatory Affairs or related field
· Knowledge of principles and regulation related to Pharmaceutical Quality Assurance and Control and Quality Management Systems is preferred
Other Skills and Abilities:
· Energetic, self-motivated, and able to work independently or team-based in a fast-paced environment
· Strong communication skills to coordinate projects between departments within the organization and with third party manufacturers or vendors
· Advanced knowledge of Microsoft Office and Adobe Acrobat
IngenusWhy Work Here?
Great opportunity for career advancement
Ingenus believes lower-cost generic medication improves patient access and offsets overall healthcare costs. Since 2010, Ingenus has helped to make a difference by developing, manufacturing and commercializing quality generic medications as cost effective solutions for patients, suppliers and stakeholders across the healthcare continuum.
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