QA Specialist

Quality Assurance Documentation SpecialistThis position provides support to various functions within Quality Assurance and reports directly to the Sr. Director of Quality Assurance. Responsibilities include the creation, organization, and review of GXP documentation, (e.g. change controls, specifications, protocols, SOPs and reports), and assisting with the coordination of training and budget activities, including purchase orders and invoices. The role assists QA product managers with responsibilities of overseeing contracted manufacturers and marketing partners, in an environment where all manufacturing/testing is contracted. This role primarily consists of ensuring documents are formatted properly, well organized in our electronic repository and readily retrievable. The successful candidate will ensure documents provided to internal/external customers are accurate, clear, and in line with Acrotech SOPs. The Specialist will also help ensure that proposed changes consider the impact to other processes, documents, budget items and external partners through a full understanding of Acrotech's processes. Based on a candidate's knowledge and experience, the role may expand into other functions as well. The ability to assist with drafting clear SOPs is important. This role provides a unique opportunity to learn many aspects of Quality Assurance within an expanding company.ResponsibilitiesOrganize documentation and ensure ease of identification and retrieval.Assist in the issuance of purchase orders, invoices, and budget development.Assist managers in the organizing, maintenance, writing and review of GxP documents related to products, production, and CMO/CTO (contractor) oversight.Compile, consolidate and review documents to prepare for and/or release product, including: Certificates of Analysis, Certificates of Conformance, Test and Batch Record Review Forms, Executed Batch Records, specifications, investigations and change controls.Review deviations, CAPA, complaint investigations and change controls for completeness, adequacy and adherence to SOPs.Author/Review SOPs.Assist with tracking the stability & reference standard programs at contractors.Consolidate documentation/data for Annual Product Reviews (APRs) and trend stability data.Track activities and create monthly metrics.Support client/regulatory audits/inspections as Scribe and process requests for documentation.Helps organize and prepare for audits/inspections. Helps to write/review observation responses. Review Status Updates to FDA.Perform additional duties as assigned by department management.Domestic and international travel possible <5%.Qualifications - Skills & RequirementsEssential skills include attention to detail; excellent organizational skills and critical thinking.Excellent communication skills – able to communicate clearly and concisely.Strong computer skills, including proficiency with MS Word, Excel, PowerPoint, and Outlook. Skills in SharePoint, Visio and Oracle a plus.Education & Experience3+ years of experience in a GMP environment such as a Pharmaceutical IndustryBachelor's Degree in chemistry, life sciences or related field with analytical laboratory experience a plus