Quality Control Associate - Alexandria, Australia - Parnell Manufacturing

Parnell Manufacturing

Verified Company

Alexandria, Australia

1 week ago

Posted by:

Olivia Brown

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Description

SALARY
A competitive remuneration package for full time employees includes:

Quarterly and Annual Bonuses
Base Salary + Superannuation

ABOUT PARNELL
Over the last 60 years, Parnell has become a leading global veterinary pharmaceutical business marketing products in 14 countries.

We have built a fully integrated animal health platform with a strong track record in research & development, we operate an FDA and APVMA accredited sterile manufacturing facility and offer unique digital technology platforms that integrate with our innovative products to offer veterinarians and animal owners superior solutions to their animal health needs.

Parnell has a strong focus on personal and professional development for those who demonstrate the company's core values of Professionalism, Excellence, and Teamwork.

Parnell rewards hard work and talent with opportunity.

Quality Control Associate - Stability
Due to personnel movements within the Quality department, there is a permanent QC associate role within the Stability Section.

As a QC Associate - Stability, you will conduct all aspects of the stability program, which will include but not limited to allocating batches, labelling and placing batches on stability, pulling and testing samples, reporting and reviewing data, and trending the results for GMP and regulatory purposes.

The main techniques involved in the position are UHPLC/HPLC using Empower 3+, Karl Fischer, Water Activity meter, balances and pH, as well as basic wet chemistry.

This person will be part of the Quality Control team, which also includes release, and manufacturing quality associates.

Strong analytical skills ideally with Waters Empower experience, along with good documentation practices are desired.

This person will also assist with release testing of raw materials, sterile and non-sterile products as and when required.

Responsibilities
The role will be reporting into the QC Team Leader - Stability:

Perform analysis of stability samples in accordance with test methods and specifications (primary function)
Ensure timely and accurate results are reported to the QC Team Leader
Stability or delegate
Competence in the operation and maintenance of instruments especially HPLC/UHPLC with Empower 3+ used in the laboratory
Reviewing of stability related documentation such as Stability Protocols, Stability Reports and QC related SOP's
Conduct out of specification and out of trend investigations in accordance with Parnell procedures
Conducting scheduled inhouse instrument calibration, maintenance, troubleshooting of instrument issues and Laboratory Housekeeping
Participate in multifunctional investigations to drive to root cause of any incidents
Prepare samples to be sent to external laboratories for testing
Participate all other QC testing as required by QC Team Leader
Stability and/or QC Associate Director

Skills & Experience

BSc or equivalent degree majoring chemistry or a related discipline
Minimum 2 to 3 years' experience in analytical testing within the pharmaceutical industry (human or veterinary)
A highly developed competence in cGMP/cGLP
Good communication skills both written and verbal
Strong writing skills relevant to quality documents and reports
Be able to work autonomously and as a team
The ability to communicate effectively with personnel from all levels
Outstanding attention to detail and the ability to identify potential issues while making timely and accurate decisions
Proactive attitude