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Quality Assurance Associate
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RK Pharma Inc Description RK Pharma Inc, a vertically integrated pharmaceutical company headquartered in NJ, is seeking a Quality Assurance Associate to work with our growing Quality Assurance Team as we scale towards commercial manufacturing in the next upcoming months. As a company focused on the development, manufacturing and sale of high quality and affordable generic pharmaceutical products worldwide, we are looking for sharp, driven, self-directed individuals to help us grow our mid-stage start-up team. This position is located in East Windsor, NJ and is required to be onsite. Requirements Bachelors degree in Pharmaceutical Sciences, Chemistry, Biology, or a related technical field. 13 years of experience in a pharmaceutical or GMP-regulated environment. Solid understanding of cGMP, GDP, and FDA regulations. Experience with batch record review, deviation handling, and change control processes. Familiarity with document management systems (e.g., MasterControl). Strong attention to detail and accuracy in reviewing technical and regulatory documents. Excellent written and verbal communication skills for cross-functional collaboration. Ability to work independently and manage multiple priorities in a fast-paced environment.
The Main Expectations And Responsibilities For This Position Are Review batch production and packaging records for accuracy, completeness, and GMP compliance prior to product release. Perform in-process line checks and quality inspections to ensure adherence to SOPs and specifications. Support deviation and change control processes, ensuring timely investigation and documentation. Participate in internal audits, walkthroughs, and inspection readiness activities. Maintain and update controlled documents, including SOPs, MBRs, and validation protocols. Collaborate with Quality Control, Production, and Engineering to resolve quality issues and drive continuous improvement. Ensure all QA activities are properly documented in accordance with GDP and data integrity principles. Support training, risk assessments, and compliance reviews as assigned by QA management.
If this sounds like something that is of interest to you, please dont hesitate to apply to start a conversation. We look forward to getting to know more about you and the skills you can bring to a company like RK Pharma Inc. Referrals increase your chances of interviewing at RK Pharma Inc by 2x. Seniority level Entry level
Employment type
Full-time
Job function
Quality Assurance Pharmaceutical Manufacturing
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Compétences linguistiques
- English
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