Quality Assurance Specialist

Jogjalowker; Kota Yogyakarta; Remote; IDR 905.141.000 - 1.448.226.000; Vollzeit

Benefits dieser Stelle

Health coverage (medical, dental, &amp

Home office stipend

Continuous learning opportunities

Equity potential

Zusammenfassung

Jogjalowker is seeking aQuality Assurance Specialist for a fully remote role to ensure all manufacturing processes and documents meet GMP/ISO standards. You will develop QA procedures, conduct audits, and drive regulatory compliance from any location.

The ideal candidate has at least 3 years of QA experience in pharma or medical devices, with strong analytical skills and the ability to work independently in a remote setting. Competitive benefits are provided.

Qualifikationen

• Bachelor's degree in Chemistry, Biology, Pharmacy, or a related field.
• Minimum of 3 years of QA experience in pharma or medical devices.
• Strong GMP knowledge and familiarity with FDA 21 CFR Part 210/211.
• Experience with audits, deviations, and CAPA management.
• Proficiency with quality management software and tools.

Aufgaben

• Develop, implement, and maintain QA protocols and SOPs.
• Conduct internal audits of processes, docs, and systems for compliance.
• Review and approve batch records, validation reports, and QA docs.
• Investigate deviations and customer complaints; implement CAPAs.
• Participate in external audits and regulatory inspections as needed.
• Monitor quality data, identify trends, and drive improvements.
• Ensure compliance with FDA regulations, ICH guidelines, and SOPs.
• Train personnel on QA procedures and best practices.
• Manage supplier quality agreements and conduct supplier audits.
• Contribute to ongoing QMS improvements.

Kenntnisse

Attention to detail

Analytical thinking

Independent work

Remote work capability

Ausbildung

Bachelor's degree in Chemistry, Biology, Pharmacy, or related field

Tools

QMS software

Jobbeschreibung

• What Quality Assurance Specialist Jobs are in...

Showing 23 Quality Assurance Specialist jobs in Godean

About the Role Our client, a significant entity in the pharmaceutical landscape, is actively seeking a dedicated Quality Assurance Specialist to join their operations. This is a fully remote position, offering unparalleled flexibility to qualified professionals. The role is pivotal in ensuring that all manufacturing processes, documentation, and products meet stringent quality standards and regulatory requirements. As a remote‑first organization, our client is committed to empowering its employees with the autonomy and resources needed to excel in their roles from any location. You will be integral to maintaining the integrity and compliance of our pharmaceutical products, contributing to patient safety and trust. This opportunity is ideal for meticulous individuals who thrive in independent work environments and possess a keen eye for detail. Your expertise will be crucial in upholding the high standards our client is known for, ensuring seamless operations and continuous improvement in quality management systems across the board. The remote setup allows for a global talent pool and fosters a culture of trust and accountability.

• Develop, implement, and maintain quality assurance procedures and protocols.
• Conduct internal audits of manufacturing processes, documentation, and systems to ensure compliance with GMP, ISO, and other relevant standards.
• Review and approve batch records, validation reports, and other critical quality documents.
• Investigate deviations, non‑conformances, and customer complaints, implementing corrective and preventive actions (CAPAs).
• Participate in external audits and regulatory inspections, acting as a key point of contact.
• Monitor and analyze quality control data, identifying trends and areas for improvement.
• Ensure that all activities comply with FDA regulations, ICH guidelines, and company SOPs.
• Train personnel on quality assurance procedures and best practices.
• Manage supplier quality agreements and conduct supplier audits as needed.
• Contribute to the continuous improvement of the Quality Management System (QMS).

• Bachelor's degree in Chemistry, Biology, Pharmacy, or a related scientific field.
• Minimum of 3 years of experience in Quality Assurance within the pharmaceutical or medical device industry.
• Strong understanding of Good Manufacturing Practices (GMP) and regulatory requirements (e.g., FDA 21 CFR Part 210/211).
• Experience with auditing, deviation investigations, and CAPA management.
• Proficiency in quality management software and tools.
• Excellent written and verbal communication skills, with the ability to document findings clearly and concisely.
• Strong analytical and problem‑solving abilities.
• Proven ability to work independently and manage multiple priorities in a remote setting.
• Detail‑oriented with a high level of accuracy.
• Familiarity with validation processes (e.g., process validation, cleaning validation) is a plus.

Our client is pleased to offer a comprehensive package for this remote role, including a competitive annual salary, performance‑based bonuses, and potential for equity participation. Employees receive excellent health coverage, encompassing medical, dental, and vision insurance, along with life and disability insurance. A robust retirement savings plan is provided with a company match. Generous paid time off, including vacation days, personal days, and holidays, is standard. We invest in our employees' growth through continuous learning opportunities, such as access to online courses, workshops, and industry conferences. A dedicated home office stipend is provided to ensure a productive remote work environment. Additionally, employee assistance programs are available for comprehensive support.

Quality Assurance Specialist - Remote Operations

Our client is a leader in the production of specialized industrial components, is seeking a dedicated and meticulous Quality Assurance Specialist to join their fully remote team. In this critical role, you will be responsible for ensuring that all manufactured products meet stringent quality standards and regulatory requirements, regardless of location. You will develop, implement, and maintain quality assurance procedures, conduct inspections and audits, and analyze quality data to identify areas for improvement. The ability to work independently, manage your time effectively, and communicate clearly in a virtual setting is paramount. This is an excellent opportunity for a QA professional who is passionate about product integrity and process excellence to make a significant impact within a forward‑thinking company that embraces remote work. You will be a key contributor to upholding our client's reputation for quality and reliability. Your insights will drive continuous improvement in our manufacturing processes and product outcomes.

About the Role

Our client, a leader in the production of specialized industrial components, is seeking a dedicated and meticulous Quality Assurance Specialist to join their fully remote team. In this critical role, you will be responsible for ensuring that all manufactured products meet stringent quality standards and regulatory requirements, regardless of location. You will develop, implement, and maintain quality assurance procedures, conduct inspections and audits, and analyze quality data to identify areas for improvement. The ability to work independently, manage your time effectively, and communicate clearly in a virtual setting is paramount. This is an excellent opportunity for a QA professional who is passionate about product integrity and process excellence to make a significant impact within a forward‑thinking company that embraces remote work. You will be a key contributor to upholding our client's reputation for quality and reliability. Your insights will drive continuous improvement in our manufacturing processes and product outcomes.

• Develop, implement, and maintain quality assurance protocols and standard operating procedures (SOPs).
• Conduct thorough inspections and testing of raw materials, in‑process materials, and finished products.
• Analyze quality data, identify trends, and prepare detailed reports on product quality and process performance.