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 patients 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. 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. 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 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/data for annual product reviews and trend stability data. Track activities and create monthly metrics. Support client/regulatory audits and inspections as scribe and process requests for documentation. 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 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 are a plus. Education & Experience 3+ years of experience in a GMP environment such as the pharmaceutical industry. Bachelor’s degree in chemistry, life sciences or related field with analytical laboratory experience (a plus). Benefits Annual bonus. Long‑term incentive plan. Medical and RX benefits – choice of four medical plans through Horizon. RX 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 and 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 with employer match; fully vested after 3 years. Employee assistance program – fully paid and confidential. Critical illness and accidental insurance. Legal and identity theft insurance. Paid time off – paid vacation, PTO, holidays. Compensation Minimum: USD 72,000 per year. Maximum: USD 81,000 per year. Physical Requirements Stand, sit, talk, hear and use hands and fingers to operate a computer and telephone; reach, stoop, kneel to install computer equipment. Specific vision abilities required due to computer work. Light to moderate lifting required. Moderate noise (business office with computers, phone, printers, light traffic). Ability to sit at a computer terminal for an extended period; sedentary work; exerting up to 10 pounds of force occasionally. 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