What are the responsibilities and job description for the Quality Assurance Specialist II position at Kindeva Drug Delivery?
Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make: As a Quality Assurance Specialist, you will play a vital role in safeguarding product integrity, ensuring regulatory compliance, and driving a culture of quality across the organization. Your contributions will directly impact patient safety, product reliability, and the overall success of our mission to deliver high-quality pharmaceutical solutions and manufacture more tomorrows. By proactively identifying risks, supporting continuous improvement, and maintaining rigorous quality standards, you will help shape the foundation of operational excellence and customer trust.
Responsibilities:
Review and approve controlled cGMP documents, including protocols, specifications, reports, and procedures.
Support the release of raw materials and finished products by auditing documentation and coordinating with Quality Control and Operations.
Participate in internal and external audits, ensuring compliance and inspection readiness.
Evaluate quality events, initiate and monitor CAPAs, and support trending and reporting for compliance activities (e.g., annual product quality reviews).
Assist with the Vendor Qualification Program, ensuring suppliers meet regulatory and company standards.
Lead or contribute to document change controls and promote adherence to safety and quality policies.
Qualifications:
Basic Qualifications:
Related BA/BS degree in scientific discipline preferred.
Knowledge of Microsoft Office programs including Word, Excel, and PowerPoint.
Qualified to work with controlled substances.
Good organization skills and attention to detail.
Ability to build and maintain positive relationships with management and peers.
Must be flexible, adaptable, and self-motivated and able to work well independently and with cross-functional teams.
Interested in learning cGMP regulations and industry standards.
Ability to change priorities in response to company demands while continuing to deliver results.
Ability to assess problems, identify solutions, plan and implement necessary changes.
Physical Requirements:
Specific vison requirements include; close vision, distance vision, color vision, and the ability to adjust and focus in order to read/understand/execute documentation as required by the position
Employee are required to follow all cGMP and safety procedures.
The employee must wear all required safety equipment and perform assigned work in a safe manner.
Employee must use proper lifting techniques and be conscious of hazards around him/her.
Must follow all GMP and safety procedures within the department.
The employee must occasionally lift and/or move up to 20 pounds.
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