The Quality Control Associate plays a key role in supporting the manufacture and release of IVF-related products through laboratory testing, data analysis, documentation management, and quality system activities. The successful candidate will work closely with Quality, Manufacturing, and external testing partners to ensure compliance with applicable quality and regulatory requirements.
Key Responsibilities Quality Control Testing
* Perform incoming goods and raw material testing.
* Conduct quality control testing of media batches and consumables.
* Perform microbiological testing and associated laboratory activities.
* Execute and support test method validation activities.
* Review and verify QC results, laboratory records, and logbooks.
* Ensure testing is completed in accordance with approved procedures and specifications.
Quality Management System (QMS)
* Support approval of incoming raw materials.
* Participate in the development and continuous improvement of QC processes.
* Investigate non-conformances and support CAPA implementation.
* Participate in Change Control and Change Request activities.
* Maintain compliance with SOPs, work instructions, and quality procedures.
* Assist in the preparation, review, and maintenance of quality documentation.
External Testing Coordination
* Coordinate internal and external testing activities.
* Liaise with external laboratories and service providers.
* Support validation and qualification of outsourced testing methods.
* Ensure timely reporting and follow-up of external testing results.
Data Management and Analysis
* Record and maintain accurate QC data and laboratory records.
* Analyze and trend quality data using monitoring and control charts.
* Escalate out‐of‐specification (OOS) or out‐of‐trend results.
* Support investigations and corrective actions arising from quality events.
Qualification and Validation
* Support qualification and validation activities for QC facilities, equipment, and test methods.
* Prepare qualification and validation protocols.
* Execute validation activities according to approved plans.
* Generate qualification and validation reports.
Quality and Compliance
* Identify and report quality risks and compliance concerns.
* Participate in internal audits and inspection readiness activities.
* Support continuous improvement initiatives across the quality function.
* Promote a quality-focused culture throughout the organization.
Health, Safety & Environment
* Follow all Work Health & Safety (WHS) policies and procedures.
* Maintain a safe laboratory working environment.
* Report hazards, incidents, and safety concerns promptly.
* Support management of chemical safety documentation, including SDS/MSDS and COSHH-related requirements.
Qualifications Required
* Bachelor's degree in Science, Biotechnology, Microbiology, Chemistry, Biomedical Science, or a related discipline.
Preferred
* Additional training or certification in Quality Assurance, Quality Control, GMP, or laboratory operations.
Experience Required
* 1–2 years of experience in a laboratory, manufacturing, pharmaceutical, biotechnology, medical device, IVF, or related regulated environment.
* Experience performing laboratory testing and documentation activities.
* Familiarity with test method validation principles.
* Proficiency with Microsoft Office applications and laboratory data management systems.
Preferred
* Experience working within ISO 13485, GMP, or other regulated quality environments.
* Experience supporting CAPA, Change Control, and validation activities.
* Experience with microbiological testing and aseptic manufacturing processes.
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