Quality Control Specialist, Sterile (Night Shift)

📋 Description • Perform in process and post production quality checks, including testing, assessing products in the compounding suites (“shop floor”) to ensure product acceptability. • Perform line clearance, where applicable. • Perform AQLs during the visual inspection process • Provide reports and trending data to QA management • Support departments in reporting, handling and escalation of investigations • Support external manufacturer non-conformance investigations to improve Quality processes. • Manage product retain samples. • Support change control system to provide improvement solutions • Support quality processes in the pharmacy – including inspections, pH meters and scale checks, non-conformance/deviation/complaint investigations, implement corrective action activities, training activities, etc. • Document & review of records: SOP generation, batch record review, COA acceptance, USP monographs, etc. • Recommend training needs, provide reports to QC Manager and Lead Pharmacist to ensure compliance with quality standards • Assist with incoming raw material inspections, as needed per the guidelines for collection, testing, and reporting quality data. • Assist with drafting SOPs and protocols to follow internal global policies, USP and other applicable regulatory guidelines • Ensures compliance with USP <795>, USP <797>, USP <800> and cGMP cleaning standards • Assist in audit activities with all appropriate third party audits & internal audits as required to ensure compliance. • Assist with the management of samples to be tested with contract laboratories. 🎯 Requirements • B.S. in chemistry, microbiology, biology, quality management, engineering, or related discipline preferred • 1-3 years experience in the area of quality assurance/control, process/quality engineering, and/or product formulation in a Sterile environment • A Pharmacy Technician license or willingness to obtain one within the first six months of employment (we cover costs and will help you obtain your trainee hours). • Experience within a 503b outsourcing facility or experience in cGMP or regulated environment with knowledge of FDA 21CFR 210 and 211, a plus • Aseptic processing experience and knowledge of ISO 14644 • Working knowledge of USP-NF standards <795>, <797>, <800> including monographs • Ability to manage multiple tasks simultaneously, with strong time management and organizational skills. • Excellent interpersonal skills, communication skills and technical writing • Solid understanding of product testing including understanding best practices for testing product against defined specifications • Ability to multi-task and work independently. Highly motivated self-starter. • Solid computer skills with Word, Excel, PowerPoint, and Google platform applications. • Excellent skills in decision making, data collection and analysis, organizing and planning. • Working knowledge and application of statistical analysis including probability and trend analysis • Knowledge and experience in documentation and facility auditing • Some local travel may be required 🏖️ Benefits • Competitive salary & equity compensation for full-time roles • Unlimited PTO, company holidays, and quarterly mental health days • Comprehensive health benefits including medical, dental & vision, and parental leave • Employee Stock Purchase Program (ESPP) • 401 (k) benefits with employer matching contribution