Quality Assurance Associate_1

Quality Associates_1 Job Responsibilities Ø Assist in ensuring compliance with quality standards, regulations, and guidelines (e.g., Good Manufacturing Practices [GMP], FDA, ICH). Ø Review and monitor batch records, documentation, and testing procedures to ensure all products meet quality specifications. Ø Help with the preparation and review of quality documentation, such as Standard Operating Procedures (SOPs), quality reports, and validation protocols. Ø Review batch production records to ensure that all steps in the manufacturing process were followed according to specifications. Ø Verify that all necessary documentation is complete, accurate, and in compliance with regulatory requirements. Ø Conduct basic laboratory testing or assist in testing raw materials, intermediates, and finished products. Ø Ensure proper calibration and maintenance of laboratory instruments and equipment. Ø Help with data collection, documentation, and analysis of test results. Ø Coordinate with the quality control (QC) and production teams to ensure corrective actions are taken when required. Ø Assist in the review and approval process for the release of finished products, ensuring they meet the necessary quality and regulatory standards. Ø Ensure that required testing and documentation are in place before products are approved for distribution. Ø Assist in internal and external audits to assess adherence to quality standards. Ø Support audit preparation and ensure that quality systems and processes are up-to-date and compliant with regulatory requirements. Ø Assist in the identification, documentation, and investigation of deviations or non-conformances in production processes. Ø Support the development and implementation of Corrective and Preventive Actions (CAPAs) to address identified issues. Ø Assist in the preparation of documentation for regulatory submissions. Ø Ensure that all records and documentation meet the standards required for regulatory inspections and audits. Ø Participate in training programs related to quality management, GMP, and other relevant areas. Ø Collaborate with cross-functional teams to resolve quality-related issues. Ø Communicate quality issues and concerns to senior management and other departments when necessary. Ø Contribute to initiatives aimed at continuous improvement in the quality management system (QMS). Ø Assist in implementing best practices to enhance product quality, reduce waste, and improve efficiency. Ø To review and or Approve/Reject the department documents such as change control, deviation, CAPA, laboratory and production failures investigation, OOS, OOT, LIR, market complaints, product recall etc. Ø To provide necessary support and inputs to R & D during product/process development, technology transfer and new product launches. Ø All other relevant duties as assigned. Benefits Ø Competitive Salary/Hourly Rate Ø Medical, Dental, Vision Insurance Ø

Paid Time Off & Holidays Physical Demands:

• Required to stand, walk, sit, talk and hear; required to use hands to operate vehicles and office equipment; must be able to occasionally lift and/or move up to 50 lbs; specific vision requirements for this job include: close, distance and peripheral vision, and the ability to adjust focus, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position without compromising patient care. • KriGen Pharmaceuticals is an equal opportunity employer. All employment decisions are made without regard to age, color, race, ancestry, national origin, disability, genetic information, military status, religion, creed, sex, pregnancy, childbirth, marital status, citizenship, sexual orientation, gender identity, gender expression, legally protected medical condition, or any other basis prohibited by applicable law. Background checks and drug screens are part of our hiring process. Affirmative Action/Equal Opportunity Employer, Minority/Female/Disabled/Veteran.

Benefits:

Dental insurance Health insurance Paid time off Vision insurance

Work Location:

In person