Technician - Process Quality Assurance Floor Support (Night Shift)Initial Therapeutics, Inc. • Durham, North Carolina, United States
Dieses Stellenangebot ist nicht mehr verfügbar
Technician - Process Quality Assurance Floor Support (Night Shift)
Initial Therapeutics, Inc.
- Durham, North Carolina, United States
- Durham, North Carolina, United States
Über
Responsibilities
Responsible for adhering to safety rules and maintaining a safe work environment for oneself and others by supporting HSE corporate and site goals.
Responsible for ensuring training is completed and remains in compliance.
Communicates with Quality Specialist Lead and QA Floor Support Supervisor on quality and operational issues.
Ensures adherence and understanding of good documentation practices and compliance with applicable procedures for both Operations and Support personnel.
Advise Operations and support personnel on quality matters, while driving the site Quality culture.
Ensures regular presence in assigned parenteral areas to monitor aseptic behaviors, GMP programs and quality systems.
Reviews and approves GMP documentation in support of daily operations such as: electronic batch record logs, paper logbooks, cleaning, and procedures versus performance.
Performs daily documented Quality Checks.
Perform sample collection, inspection, and delivery of samples to storage location and/or laboratory.
Troubleshoot and provide QA systems support to reconcile issues in systems, such as inventory control systems (SAP), laboratory LIMS system (Darwin) and other systems as required (TrackWise, PMX).
Participate in self-led inspections and provide support during internal / external regulatory inspections.
Ability to work cross functionally and work collaboratively with all levels of the organization.
Qualifications
Required: High School Diploma or equivalent
Required: Legally authorized to be employed in the United States (no visa sponsorship anticipated)
Required: Completion of Post Offer Exam or completion of Work Simulation if applicable
Required: Ability to work overtime, as requested
Preferred: Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field
Preferred: Demonstrated knowledge of pharmaceutical processes and Quality Systems
Preferred: Knowledge of inventory management and deviations systems (e.g., SAP, TrackWise)
Preferred: Experience with combination products or devices and relevant US/EU regulations
Preferred: Experience in GMP production environments
Preferred: Facility or area start-up experience
Preferred: Knowledge of Validation / Qualification activities
Preferred: Strong decision making and problem-solving skills
Preferred: Strong attention to detail; ability to work independently or as part of a team
Skills
Strong oral and written communication
Interpersonal skills
Cross-functional collaboration
Quality systems and GMP awareness
Education
High School Diploma or equivalent (Required)
Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field (Preferred)
Additional Requirements
Night shift: Support a 24/7 operation with rotating twelve-hour shifts. Onboarding may start with eight-hour Monday-Friday day shift before transitioning to the rotating schedule.
Mobility: May work in various areas within the DAP and Warehouse buildings; mobility requirements should be considered when applying.
#J-18808-Ljbffr
Sprachkenntnisse
- English
Hinweis für Nutzer
Dieses Stellenangebot wurde von einem unserer Partner veröffentlicht. Sie können das Originalangebot einsehen hier.