Job Description

Join to apply for the Quality Assurance Associate role at 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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