Manufacturing Quality Associate

4 weeks ago

Alexandria, Australia Parnell Manufacturing Full time

As an Manufacturing Quality Associate (MQA), you will conduct all aspects of the MQA responsibilities, which will include but not limited to line clearances, sampling of ancillary and packaging materials, AQL inspections, non-viable monitoring during batch manufacture, controlled label management, testing of Water For Injection (WFI)/Clean Steam (TOC, Conductivity, Nitrates), temperature monitoring of sample/material storage areas, along with seal integrity of finished products. The tasks will also include reviewing, reporting and trending of data.

The MQA team is also responsible for the maintenance for the visual inspection library, training new, and requalifying current inspectors.

Additionally, in the MQA role you will be expected to conduct and support the Quality function by completing Out Of Specification (OOS) investigations, Corrective and Preventative investigations, Deviations, Change Controls, and document updates.

This person will be part of the Quality Control team, which also includes release, and stability associates within the respective sections in the department.

**Responsibilities**

The role will be reporting into the MQA Team Leader:

- Perform all aspects of the production/manufacturing checks as required (e.g. line clearances, AQLs - as listed above)
- Ensure timely and accurate results are reported to the MQA Team Leader
- Competence in the operation and maintenance of instruments especially in relation to temperature monitoring of samples/materials
- Reviewing of MQA related documentation such as SOP’s
- Conduct out of specification and out of trend investigations in accordance with Parnell procedures.
- Conducting scheduled in-house instrument calibration, maintenance, troubleshooting of instrument issues and laboratory housekeeping
- Participate in multifunctional investigations to drive to root cause of any incidents.
- Prepare and send samples to be sent to external laboratories for testing.
- Participate all other QC/MQA tasks as required by MQA Team Leader and/or QC Associate Director.

**Skills & Experience**
- BSc or equivalent degree majoring chemistry or a related discipline
- Minimum 1 years’ experience in analytical testing within a similar field in the pharmaceutical industry (human or veterinary)
- A highly developed competence in cGMP/cGLP
- Outstanding attention to detail and the ability to identify potential issues while making timely and accurate decisions.
- 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.
- Proactive attitude that can motivate others to achieve common business goals.

**Job Types**: Full-time, Permanent

**Salary**: From $60,000.00 per year

**Benefits**:

- Childcare assistance
- Paid volunteer leave
- Professional development assistance
- Referral program

Schedule:

- 8 hour shift
- Monday to Friday

Supplemental pay types:

- Performance bonus

Ability to commute/relocate:

- ALEXANDRIA, NSW 2015: Reliably commute or planning to relocate before starting work (required)

Work Authorisation:

- Australia (required)

Work Location: One location

Expected Start Date: 27/03/2023

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