Quality Assurance Officer

Fresenius Medical Care; Sydney; On-site; AUD 90,000 - 115,000; Full time

Job summary

Fresenius Medical Care in Australia is seeking a Quality Assurance Officer - QMS, Products to support GMP/ISO compliant QA activities. You will perform sampling, testing, and data recording, ensuring all operations meet GMP, NID and ISO standards while assisting with internal audits and QA process improvements.

The role requires a tertiary science qualification and at least 1 year in a GMP/Medical Devices/ISO certified environment, with strong communication and computer literacy to manage high

Qualifications

• Minimum 1 year experience in GMP/Medical Devices/ISO environment.
• Excellent written and verbal communication skills.
• Ability to manage a high throughput of work with quality deadlines.
• Strong computer literacy and data recording skills.

Responsibilities

• Perform sampling and testing according to SOPs.
• Ensure activities meet GMP and ISO guidelines and FMC standards.
• Assist in internal audits for compliance with FMC quality systems.
• Carry out other projects as directed by QA Manager/Lab Supervisor.
• Maintain safe working practices and WHS compliance.

Skills

QA experience

GMP knowledge

ISO knowledge

Documentation skills

Communication skills

Computer literacy

Education

Tertiary qualification in science

Job description

Position Summary:

The role of the Quality Assurance Officer - QMS, Products is to:

• Perform QA activities to support the quality system and ensure all activities meet GMP guidelines, NID regulations and ISO Standards.
• Carry out sampling and testing in accordance with the Quality System and GNIP regulations.
• A tertiary qualification in a relevant scientific discipline or equivalent, with a minimum of 1-year experience in a GB P/ ISO certified environment.

Key Responsibilities / Authorities:

OC Sampling & Testing:

• The Quality Assurance Officer will carry out sampling and testing according to standard operating procedures.
• Ensure all activities meet GMP and ISO guidelines as specified by FCC quality system and training.
• Ensure all activities are carried out in a safe manner and according to Workplace Health and Safety regulations.
• Sampling and testing of packaging materials, raw materials, intermediate products and finished products to verify they meet specifications.
• Assist production staff in relation to any information or guidance required for quality issues in conjunction with Laboratory management.
• Ensure compliance for laboratory activities undertaken within FMC guidelines.
• Send samples to approved contract testing laboratories.
• Preparation of solutions and reference standards.
• Approve all chemical reagents before use.
• Check the calibration status of all laboratory equipment before use. Ensure that all laboratory equipment is calibrated as per the calibration schedule.
• Ensure laboratory data is recorded on the appropriate registers.
• Perform stability testing on haemodialysis solutions as per the stability studies schedule.
• Maintain orderly storage of retention samples.
• Notify the QA Manager / Lab Supervisor of any discrepancies or out of specification results inn mediately.
• Only approve products for further processing that test within specification.
• Ensure the lab supervisor is advised of any low stock materials used in the laboratory including chemicals and glassware.
• Ensure that all data is recorded on the correct forms in real time.
• Ensure that changes to any recorded data are only made in the correct manner and signed and dated as per training.
• Assist in internal audits for compliance with FMC quality systems.
• Carry out other projects as directed by the Quality Assurance Manager/ Laboratory Supervisor.

Ouality Management Systems:

• Assist in the developmentand maintenanceof QualitySystems and provide support and guidanceto ensure compliancewithapplicablestandards.
• Assist with Non-conformance and Deviation Management. Ensure corrective / preventative actions are taken and are effectively implemented.
• Review and maintain specifications, standard operating procedures and other quality documents.
• Work closely with other departments to ensure staffs are working in compliance with internal policies and procedures.
• Assist with the development and implementation of QA process improvements.
• Ensure all activities are carried out in a safe manner and according to Work, Health and Safety regulations.
• Assist in internal audits for compliance with FMC quality systems.
• Assist in introduction of global documents, policies for effective implementation on site
• Carry out other projects as directed by the Sr Quality Assurance Manager.

Business Expansion / Product Introduction:

• Assist Sr QA associate in establishing quality plans and related activities for Smithfield.
• Assist Sr QA associate in managing site QMS effectively, ensure ISO and EU MDR certification is maintained during project roll overs.
• EnsureQA/productcompliancemaintainedfor Smithfieldproductprofile (both Smartbags and ProcedurePacks)

Description of Qualification, Key Skills, Personal Attributes:

• A tertiary qualification in a relevant scientific discipline or equivalent.
• Minimum 1-year experience in a GMP, Medical Devices and/or ISO certified environment.
• Excellent written and verbal communication skills.
• Ability to manage a hig h throughput of work while meeting quality and business requirements and deadlines by having excellent organisational skills.
• Computer literacy.
• Good English Literacy and numerical skills.