QA Oversight Specialist II
6 days ago
Cytovance Biologics is seeking a highly skilled QA Operations Associate II to maintain quality oversight of operational areas, ensuring compliance with cGMPs and company procedures. The successful candidate will work closely with Operations personnel and perform various checks during manufacturing processes to guarantee adherence to regulatory and quality standards.
- Ensures compliance with cGMPs and company-specific procedures.
- Reviews records to guarantee accuracy and completeness, adhering to GMP and GDP requirements.
- Reports errors, deficiencies, and observations to management.
- Performs quality functions in classified areas, including process audits, room releases, documentation review, acceptance sampling, product and sample collection, and inventory control and retain inspections.
- Interfaces with functional groups to identify events and report to management, potentially halting operations when product safety is compromised.
- Supports Quality System requirements, including initiating and authoring Planned and Unplanned Deviation Reports, Nonconforming Material Reports, and Corrective/Preventive Actions.
- Applies quality compliance theories and principles to address moderate-scope issues independently.
- Interfaces with client QA as directed, providing notification of events impacting client product and materials.
- Provides guidance on controlled documents, identifying gaps and suggesting process improvements.
- Performs and analyzes event trending to identify areas for improvement.
- Initiates and participates in SOP and MBR revisions to enhance compliance.
Requirements:
- Bachelor's Degree with a focus on physical or life sciences, or equivalent experience.
- 2-4 years of relevant Quality Systems experience, preferably in an FDA-regulated manufacturing facility. 6+ years with a college degree substituted with experience.
- Ability to read, analyze, and interpret common scientific and technical information in English.
- Ability to respond to inquiries or complaints from internal and external customers and regulatory agencies.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret technical instructions and deal with abstract and concrete variables.
- Proficiency in Microsoft Office software: Excel, Word, Outlook, and PowerPoint.
We are an Equal Opportunity Employer.
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