Quality Control Specialist
- Perform in process and post production quality checks, including testing, assessing products in the compounding suites 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 Supervisor 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
- 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.
- B.S. in chemistry, microbiology, biology, quality management, engineering, or related discipline
- 1-3 years experience in the area of quality assurance/control, process/quality engineering, and/or product formulation
- A Pharmacy Technician license or ability 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 (Current Good Manufacturing Practice) or regulated environment with knowledge of FDA 21CFR 210 and 211, a plus
- Aseptic processing experience and knowledge of ISO 14644
- Excellent interpersonal skills, communication skills and technical writing
- Solid understanding of product testing including understanding best practices for testing product against defined specifications
- 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 good documentation practice and facility auditing
- Overall willingness to learn, work, and assist/train in any pharmacy related tasks and are able to adapt to fast-changing conditions
- Some travel may be required
- 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)
- 401k benefits with employer matching contribution
- Offsite team retreats
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