AddressIMMEDIATE START
Immediate start is available
SALARY
1 x Full Time Permanent Position
- Base Salary + Bonus + Super
- Free Car Park for all staff on site
- Office perks including office massage & stocked lunch room
- Strong company culture
ABOUT PARNELL
Parnell Veterinary Pharmaceuticals is a global animal health company based in Alexandria, Sydney with a focus on innovation and rapid growth. Our unique digital technologies integrate with our innovative products to provide veterinarians, producers and pet parents with unique solutions for their animal health needs. We offer personal and professional development opportunities for those who demonstrate the company's core values of Professionalism, Excellence, and Teamwork, Safety and Sterility and an exciting, fast-paced and entrepreneurial work environment.
THE POSITION
We are seeking a Microbiology Associate to join our team! The primary responsibility of the Microbiology Associate will be to perform tasks related to the Parnell environmental monitoring program, conduct in-house endotoxin and bioburden testing and assist with the media fill validation and sterility assurance programs to ensure the manufacture of sterile and safe products for all relevant regulatory jurisdictions (US FDA, APVMA). This position reports to the Microbiology and Sterility Assurance Manager.
ABOUT YOU
We will consider candidates that demonstrate the following:
· A culture of execution with a ‘Right first time’ mindset
· Team player who is both focused on success and has ability to work independently and own their role
· Advanced written and verbal communication skills and a strong aptitude to prioritise your work
· Strong adherence to Continuous Improvement and solutions based thinking
WORK EXPERIENCE & SKILLS
Responsibilities
- Contribute to the development and maintenance of cGMP compliance in production applicable to all relevant regulatory jurisdictions.
- Performing all aspects of the environmental monitoring program which includes but is not limited to, sample selection, sample placement, adding/removing samples, testing (e.g. reading plates), reporting, trending and reviewing of data according to cGMP and company standard operating procedures at all times
- Conduct in-house bacterial endotoxin testing according to cGMP and company standard operating procedures at all times
- Undertake microbiological out-of-specification and out-of-trend (MOOL/MOOT) investigations, document updates, deviation reporting, corrective and preventative (CAPA) investigations, and trend data analysis (where required).
- Assist in the oversight of the Parnell Sterility Assurance Program and activities that support sterility assurance including but not limited to filtration, gowning, aseptic technique, sterilization, depyrogenation, media fills, seal integrity, cleaning practices and materials, water systems and sterility testing.
- Assist in managing media fill validation program.
- Undertake the installation and qualification of microbiological equipment
- Conduct internal audits as required
- Assist with the strategic development, implementation and continuous improvement of existing and new best-practice Quality Management Systems particularly for the Microbiology Laboratory.
- Contributes to the daily operations of the Micro Laboratory housekeeping
- Provide support for the test method validation program
- Responsible for equipment in the Micro Laboratory Calibration and Maintenance Program
- Review of analyses, EM test records and logbooks where required
ESSENTIAL SKILLS
- B.S. degree in Microbiology or related field required
- 1-2 years pharmaceutical experience
- Experience in a sterile manufacturer would be highly regarded
