Insight Global is a hiring a GMP Operational Specialist for our pharmaceutical client in Providence, RI. This role focuses on compliance, quality processes, documentation control, and quality control activities for our medical device manufacturing operations. The ideal candidate will have a strong background in QA within the medical device or a similarly regulated industry. Key responsibilities include:
-Incoming Material Inspection: Conduct inspections, document results, and address quality issues with suppliers and internal teams.
-Document Control: Manage and distribute quality documentation, ensuring compliance with regulatory requirements.
-Quality System Oversight: Maintain the quality management system (QMS), investigate quality issues, and implement corrective actions.
-Additional Support: Assist with process improvement projects, risk assessments, validation activities, and generate quality reports.
This role is perfect for someone with a keen eye for detail, a commitment to quality, and a desire to grow within the medical device field.
Pay Range: $35/hr-$45/hr (Pay Range is determined by multiple factors including years of experience, industry background, level of degree, etc.)
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to
[email protected].
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-Bachelor's degree in Engineering or a related Science field
-2-3 years in a quality-related role, preferably in medical device manufacturing or a regulated industry (internship experience is acceptable).
-Knowledge of quality standards and regulatory requirements, such as ISO 13485 and FDA regulations.
-Basic understanding of inspection methods, document control procedures, and quality management systems.
-Strong organizational and communication skills, with a keen eye for detail and accuracy.
-Proficiency in Microsoft Office (Word, Excel, PowerPoint); familiarity with QMS or ERP software is advantageous.
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.