Associate Scientist-Chemistry I (Australia)

JOB SUMMARY

Performs a variety of technically diverse assignments to support the analytical testing, review, and release of products for the Australian market under the guidance and supervision of the supervisor. Responsibilities include conducting annual Product Quality Reviews (PQRs) and trend analyses; reviewing batch records and associated documentation(Deviations, PCF, NCMRs, or Risk Assessments) for compliance with Australian regulatory requirements; preparing and maintaining Australian product specifications; and providing technical and quality documentation to support regulatory, customer, and business requests as needed. Under supervision, ensures activities are completed accurately, efficiently, and in accordance with applicable quality and regulatory standards.

Key Responsibilities

• Conduct assigned Quality Control (QC) testing and related activities for raw materials and finished products to support the quality and regulatory requirements of the Australian market.
• Perform Quality Assurance (QA) reviews of regulatory and quality documentation to ensure compliance with applicable requirements.
• Conduct Acceptable Quality Level (AQL) audits and document findings in accordance with established procedures.
• Provide product information, technical data, and supporting documentation as required to meet Australian regulatory and customer requirements.
• Maintain a safe, clean, and organized work environment while adhering to company policies and Good Manufacturing Practices (GMP).
• Collaborate with cross-functional teams to support quality, regulatory, and operational objectives.
• Perform other duties and responsibilities as assigned.

Qualifications

• Bachelor's degree (B.S.) in a scientific discipline relevant to the company's operations, such as Chemistry, Biology, Microbiology, Botany, or a related field.
• Minimum of three year of relevant industry experience, or a Master of Science (M.S.) degree in a related scientific field with limited professional experience.
• Working knowledge of scientific principles, including mathematics, chemistry, botany, and/or microbiology.
• Familiarity with current Good Manufacturing Practices (cGMPs), and Acceptable Quality Level (AQL) audit
• Basic understanding of Therapeutic Goods Administration (TGA) regulations(PICs Guidelines) and requirements applicable to NSP products.
• Ability to operate a variety of laboratory equipment, perform analytical procedures, and effectively utilize quality and documentation management systems(HPTLC, HPLC, FTIR, and Wet Chemistry).
• Demonstrated flexibility and adaptability in a dynamic work environment.
• Strong interpersonal skills with the ability to work effectively as a collaborative member of a team.
• Ability to maintain accurate, detailed, and complete records in accordance with quality and regulatory requirements.
• Strong organizational and time-management skills, with a demonstrated ability to prioritize tasks and meet established deadlines.