Opella
Pharmaceutical
QualityAssociate
Neural analysis suggests this role is
optimal for Entry candidates.
“Quality Associate at Opella. Skills: Quality assurance, Validation, Calibration. Manage quality assurance systems. Manage qualification and validation activities”
Industry & Context.
Root cause analysis; Problem-solving
What They're Looking For.
Must Have
Experience in pharmaceutical, complementary medicine, or OTC manufacturing within a GMP/cGMP-regulated environment, Knowledge of Quality Management Systems (QMS), including deviations, CAPA, non-conformances, change controls, and document control, Hands-on experience with validation and qualification activities (IQ/OQ/PQ, process validation, cleaning validation, HVAC, utilities, equipment), Knowledge of calibration management, maintenance coordination, and working with external contractors/vendors, Experience with Computer Systems Validation (CSV), spreadsheet validation, data integrity, and regulatory compliance (TGA/PIC/S GMP), technical writing, root cause analysis, problem-solving, audit/inspection readiness skills, Ability to collaborate cross-functionally with Manufacturing, Engineering, QC, Supply Chain, and Regulatory Affairs teams while managing multiple priorities
What You'll Do.
Manage quality assurance systems
Manage qualification and validation activities
Manage change controls
Manage computer systems validation
Manage self-inspection
Process Non-Conformances
Process Process Deviations
Process Compliance Issues
Process Quality Observations
Drive Change control activities
Assist in creation of new documentation
Review existing documentation
Manage Site Validation Master Plan
Manage validation related activities
Manage planning & reporting of validation
Manage calibration activities
Schedule External Contractors
Facilitate cross-functional working relationships
Manage interactions between team and stakeholders
Assist in investigations
Assist in management of Quality Systems
Assist in coordination of Quality Systems
Provide Technical advice
Provide Technical expertise
Provide technical support
How You'll Work.
Team & Collaboration
Collaborate cross-functionally with Manufacturing, Engineering, QC, Supply Chain, and Regulatory Affairs teams; Facilitate the cross-functional working relationships of the team; Manage interactions between the team and key stakeholders including, External contractors, Operations, Engineering, Occupational Health & Safety, QC, ID&I and Regulatory Affairs
Process & Methodology
Management of change controls, Manage validation related activities, Manage the planning & reporting of all Virginia site validation and calibration activities
Full Job Description
**Job title:** Quality Associate **Location:** Virginia, Brisbane. You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As an [Experienced Hire Role], you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human. **About the job** The Quality Associate reports directly to the Quality Systems and Technical Lead and is responsible for all quality assurance systems and qualification and validation activities for the Virginia manufacturing site. This is a technical role and includes management of change controls, qualification, validation, computer systems validation, self-inspection and third-party management. Products manufactured in the Virginia site comprise both of listed and registered complementary medicines and a growth view for the manufacture of Over The Counter (OTC) products, with distribution both locally in Australia and within the Asia Pacific region. **Main Responsibilities** This is a highly collaborative role with key stakeholder management cross-functionality whilst assuring Quality in the areas of manufacturing, engineering, supply chain and Quality Control. Main responsibilities and accountabilities include: **Quality Compliance** * Manage and assist in the processing of Non-Conformances, Process Deviations, Corrective & Preventative Actions, Compliance Issues, Deletions & Quality Observations and associated documentation and filing of both physical and electronic documents, in line with Organisational, Regulatory and Environmental Standards. * Manage and Drive Change control activities related to Validation and Calibration of new equipment and processes. * Assist in the creation of new documentation and review existing documentation associated with equipment and processes within the facility. **Validation** * Manage the Site Validation Master Plan as required to e
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