Quality Assurance Associate III in Waltham, MA

Mon-Fri 8am-5pm or 9am-6pm.

The position will onboard in January

Hybrid Role

Open to candidates willing to relocate at their own expense Final round interviews will be required onsite

Must Have Experience

• Bachelor’s and/or 8+ years of relevant experience
• Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences) – must be specific to pharm industry
• PHD may be considered overqualified
• Issue/Review documentation, i.e. Deviations, CAPAs, OOS etc., as they occur.
• Write and revise SOP, forms, WI, and any other document types
• Assist with internal and external audits.
• Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.

 Nice to Have Experience:

• investigation or product complaint experience

The Requirements for this position is:

• Bachelor’s and/or 8+ years of relevant experience
• Minimum 5 years of experience in Quality Assurance (Prefer Lot release experiences)
• 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.

This role will be:

• Reviews executed batch records and related documentation, resolves compliance issues and dispositions lots of drug substance, bulk drug product, drug product and clinical materials for use in clinical trials
• Perform lot release Quality Review of manufacturing and quality control records to ensure compliance with specifications and regulations.
• Ensure that all requirements, as stipulated in the appropriate QTA, have been met.
• Issue/Review documentation, i.e. Deviations, CAPAs, OOS (out of spec) etc., as they occur.
• Write and revise SOP, forms, WI, and any other document types
• Assist with internal and external audits.
• Support of data analysis and metrics for QMR, KPIs, and other reportable forums may be requested.
• Assume additional responsibilities as assigned.

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. We specialize in attracting and retaining talent globally for rewarding careers in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, whether in the USA, UK, India, or Ireland. Additionally, we offer Location Independent jobs and contract positions across different verticals and industries.
Rangam strives to put job seekers first, providing them with free access to search for jobs, post resumes, and research companies. Every day, we connect millions of people to new opportunities.