Arbetsbeskrivning

Job Purpose

The Quality Assurance Specialist supports the internal stakeholders, including the ISO 17025 certified lab, research and development team, and manages quality-related activities including CMO qualification, outsourced activities, and quality management system tasks. This role is crucial in ensuring the release of high-quality products and maintaining compliance with regulatory standards.

Duties & Responsibilities

The key responsibility for the role includes:

• ISO 17025 Quality Support: Ensure compliance with ISO 17025 standards in laboratory operations and testing procedures.
• Organize and conduct internal and external meetings regarding complaints, reports and deviations
• Reviewing the validating certificates on ISO 17025 certified equipment
• Draft and update instructions, reports such as validation reports and nonconformities within the quality system of the laboratory
• Certified QC Lab Support:
• Quality Assurance Consultation: Provide expert QA consultation to the QC lab, addressing any quality assurance-related questions.
• Scientific Guidance: Offer scientific guidance to the QC lab to ensure accurate and reliable testing results.
• Stability Assessment: Address stability-related questions and ensure proper stability testing procedures are followed.
• Equipment Management: Assist with equipment management activities, including calibration, maintenance, and validation
• Support for Internal Stakeholders:
• Research and Development Support: Collaborate with R&D teams (Product and Application (P&A) team) to ensure quality standards are met in all research activities.
• Supply Chain department: Work closely with the supply chain department to ensure quality standards are maintained throughout the procurement and distribution processes.
• Sales activates: Assist the sales department in addressing quality-related inquiries and ensuring customer satisfaction.
• Customer Support:
• Complaint Handling: Address and resolve customer complaints related to product quality, ensuring timely and effective communication.
• Quality Inquiries: Respond to customer inquiries regarding product quality (e.g. ingredients, methods, suppliers, specifications, stability data and packaging materials) and provide necessary information and support, including providing input to customer questionnaires.
• CMO Qualification: Evaluate and qualify Contract Manufacturing Organizations (CMOs) to ensure they meet quality standards.
• Outsourced Activities: Monitor and manage quality aspects of outsourced activities to ensure compliance with company standards.
• Quality Management System (QMS):
• Deviation Handling: Investigate and resolve deviations in processes and procedures.
• Change Control Management: Manage changes in processes, equipment, and documentation to ensure compliance. Communicate changes with external stakeholders by sending out Change Control requests to CMOs and to the customers.
• Documentation Management: Maintain accurate and up-to-date documentation within the QMS.
• Product Release: Oversee the release of products, ensuring they meet all quality and regulatory requirements.

Qualifications

• Master’s degree in a related field (e.g., Chemistry, Biology, Quality Management).
• Minimum of 3 years of experience in qualityform the food or supplement industry, preferably in an ISO 17025 certified environment.
• Strong knowledge of quality management systems and regulatory requirements.
• Proficiency in Microsoft Word and Excel.
• Excellent analytical and problem-solving skills.
• Effective communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Fluent in English, both oral and written