Quality Assurance Specialist

Job Purpose

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.

o   Organize and conduct internal and external meetings regarding complaints, reports and deviations

o   Reviewing the validating certificates on ISO 17025 certified equipment

o   Draft and update instructions, reports such as validation reports and nonconformities within the quality system of the laboratory

·       Certified QC Lab Support:

o   Quality Assurance Consultation: Provide expert QA consultation to the QC lab, addressing any quality assurance-related questions.

o   Scientific Guidance: Offer scientific guidance to the QC lab to ensure accurate and reliable testing results.

o   Stability Assessment: Address stability-related questions and ensure proper stability testing procedures are followed.

o   Equipment Management: Assist with equipment management activities, including calibration, maintenance, and validation

·       Support for Internal Stakeholders:

o   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.

o   Supply Chain department: Work closely with the supply chain department to ensure quality standards are maintained throughout the procurement and distribution processes.

o   Sales activates: Assist the sales department in addressing quality-related inquiries and ensuring customer satisfaction.

·       Customer Support:

o   Complaint Handling: Address and resolve customer complaints related to product quality, ensuring timely and effective communication.

o   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):

o   Deviation Handling: Investigate and resolve deviations in processes and procedures.

o   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.

o   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.

Authorized to:

·       Issue and co-sign certificates/analysis reports

·       Review and approve calibration, maintenance, and validation reports on equipment

·       Draft, review and approve QMS documentations

·       To act as Deputy for the Senior Quality Manager within the ISO 17025 accredited activities

·       To act as backup and sign on behalf of the Senior Quality Manager in her absence

Qualifications

·       Master’s degree in a related field (e.g., Chemistry, Biology, Quality Management).

·       Minimum of 3 years of experience in quality from the food or supplements 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