QA Specialist

Division Overview Acrotech Biopharma Inc. was formed as a global platform to commercialize innovative proprietary medications. The company aims to launch scientifically advanced products to address unmet needs and deliver value to patient's as well as all healthcare stakeholders. Acrotech aspires to be a patient focused, research-based organization that strives to launch treatments which are accessible to patients that need them. Acrotech Biopharma is focused on building a presence in unmet needs in oncology and dermatology. We are currently building out a new Dermatology Business Unit to launch ADQUEY a novel treatment for mild to moderate Atopic Dermatitis. This is a great time to join Acrotech. We are seeking talented leaders to grow our organization. Here you won’t be just a number, but a key contributor who will make significant impact on our organization and the patients we support. Job Overview This 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. Responsibilities Organize 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 and review SOPs. Assist with tracking the stability and reference standard programs at contractors. Consolidate documentation and data for annual product reviews (APRs) and trend stability data. Track activities and create monthly metrics. Support client and regulatory audits and inspections as scribe and process requests for documentation. Help organize and prepare for audits and inspections. Write and review observation responses. Review status updates to FDA. Perform additional duties as assigned by department management. Domestic and international travel possible Qualifications – Skills & Requirements Essential 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 & Experience Three years of experience in a GMP environment such as a pharmaceutical industry. Bachelor’s degree in chemistry, life sciences, or a related field with analytical laboratory experience a plus. Benefits Annual bonus. Long‑term incentive plan. Medical and prescription benefits – choice of four medical plans through Horizon. Prescription medication automatically provided with medical benefits. Dental benefits with three dental plan options through Cigna. Vision plan with two plan options through VSP. Life insurance: basic life, AD&D, and supplemental life insurance. Disability insurance, voluntary short‑term disability and state disability – long‑term disability (LTD), state short‑term disability where applicable. Flexible spending accounts – health care and dependent care available. Health savings account. 401(k) plan through Fidelity with employer match and fully vested after three years. Employee assistance program – 100% confidential and fully company paid. Critical illness and accidental insurance. Legal and identity theft insurance. Paid time off – paid vacation, PTO, and holidays. Compensation Minimum: USD 72,000.00 per year. Maximum: USD 81,000.00 per year. Physical Requirements Office position. While performing the duties of this job, the employee is required to stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone keyboard, reach, stoop, kneel to install computer equipment. Specific vision requirements include close vision for computer work. Light to moderate lifting is required. Moderate noise (business office with computers, phone, and printers, light traffic). Ability to sit at a computer terminal for an extended period of time. Sedentary work; exerts up to ten pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids, or tissues. Category I tasks are not a condition of employment. #J-18808-Ljbffr