Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse
Job Description
Position Summary:
Lead Quality and Logistics functions on site, by being accountable for the quality management system and procurement and supply chain activities related to raw materials, intermediates and finished product. This role has a matrixed reporting to the Site Manager and Senior Manager, Quality Systems (ANZ BCD).
Key Responsibilities:
Quality
- Ensure all quality assurance and quality control tasks on site, including but not limited to documentation, environmental monitoring, deviation and change control activities are completed in a manner aligned with cGMP/ISO principles, company policies and procedures.
- Complete quality documentation review and ERP release of production components, raw materials and final product at the Newcastle site for further manufacturing and for supply.
- Lead the receipt and export of raw serum quality samples, produced by both Thermo Fisher Scientific and third-party suppliers, to Auckland for quality control testing.
- Lead on-time revision of quality documents, including standard operating procedures, standard forms, batch manufacturing records and related documentation. Support training on site.
- Ensure that deviations, non-conformances, customer complaints and internal audits pertaining directly to Newcastle site are performed and investigated in compliance with relevant procedures. Apply root cause analysis tools in a timely manner to support problem solving.
- In conjunction with the Production Supervisor, be accountable for aseptic cleanroom operational activities. This includes staff training, rostering, setup, dispensing, monitoring, sampling and testing ensuring segregation of manufacturing and quality activities.
- Ensure that environmental monitoring activities and media fill reads are performed in strict compliance to quality standards, reviewed appropriately and processed independently of production activities.
- Lead and co-ordinate regulatory and customer audits for the site.
- Support supplier audit management programs on and off site.
Logistics and Operational Support
- Work closely with third party transport providers to arrange the shipping of raw materials, semi-finished and finished goods domestically and internationally. Follow local and international regulations and company procedures.
- Stay informed and updated about regulatory requirements for importing and exporting products from Australia and to our diverse export markets
- Produce the regulatory documentation important for the import/export of non-edible meat products to/from the site, other company sites and customer sites worldwide.
- Maintain records of export documentation in compliance with Department of Agriculture Forestry and Fisheries (DAFF), Australian Customs, our requirements
- Act as Subject Matter Authority within the team and region for import/export processes and documentation.
- Support inventory accuracy initiatives to align with corporate requirements
Workplace Health and Safety (WHS)
Follow all SafeWork NSW legislation and company WHS procedures and policies, report potential hazards and provide input into the resolution of WHS hazards / issues.
- Assure operations are aligned with government and company legal requirements
- Ensure all colleagues and visitors comply to safety requirements
- Assure all colleagues follow safe work practices on site and support leadership initiatives to enhance and improve our safety culture
Practical Process Improvement (PPI)
- Promote continuous process improvement initiatives through applying tools and training of colleagues in Practical Process Improvements (PPI)
- Utilise AI to improve work flows and create task efficiencies
General Activities
- Demonstrate the companies 4i Values in all interactions with colleagues, customers and suppliers.
Support the efficient and effective operation of the business by being available for other tasks as prioritised.
- Ability to work overtime and be flexible around hours and days of work when required
Minimum Requirements/Qualifications:
A science and/or quality qualification and 3 – 5 years of applicable experience in a mid to large manufacturing company involved in food, diagnostic or pharmaceutical production
Competencies:
- Effective communicator, collaborative and inclusive with a focus on continuous improvement, agility and customer requirements.
Personal Qualities:
Must be proactive, motivated, accountable and can multitask and adapt to change