Quality Assurance Associate II

2 days ago

Waltham, United States Pyramid Consulting Full time

Immediate need for a talented Quality Assurance Associate II. This is a 12months contract opportunity with long-term potential and is located in Waltham, MA, (Onsite). Please review the job description below and contact me ASAP if you are interested. Job ID: 24-51470Pay Range: $40 - $43/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).Key Responsibilities: Review and approve Master Manufacturing Records, Stability Protocols and Reports, Sampling plans, and associated manufacturing documents for the timely initiation of GMP manufacturing activities. Perform QA review of Executed Batch Records. Perform QA review of Quality Records, i.e. Deviations, CAPAs, OOS etc., as they occur. Perform QA review and approval on SOPs, forms, WI, and other document types. Provide SAP support for GMID and BOM approval. Provide Quality oversight and Quality guidance to resolve compliance issues for lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials. Ensure all requirements, stipulated in the CMO Quality Agreements, are being met. Review and Approve Analytical related documents such as Test Methods, Test Method Transfer Plans and Assessments, if needed. Participate in Quality Risk Assessments Assist with internal and external audits. Support of data analysis and metrics for Quality Council, KPls, and other reportable forums may be requested. Assume additional responsibilities as assigned.Key Requirements and Technology Experience: Key skills; Deviation, Veeva, CAPA, Batch Records Bachelor's and/or 8 years of relevant experience Minimum 5 years of experience in Quality Working knowledge and ability to apply Quality principles and cGMPs in conformance to standards, preferably gained from working in a manufacturing, QA or QC environment. Demonstrated ability to interact and communicate effectively, both written and verbal, with peers, management, auditors, and consultants. Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines. Preferred experience with outsourced manufacturing and testing operations Working knowledge of MS Office products including Word, Excel, Outlook, PowerPoint, and Project. Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.mor

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