Opella

Pharmaceutical

QualityAssociate

Virginia FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Entry candidates.

The Brief

“Quality Associate at Opella. Skills: Quality assurance, Validation, Calibration. Manage quality assurance systems. Manage qualification and validation activities”

Industry & Context.

Pharmaceutical
Problems you'll solve

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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