Associate Specialist, Quality Assurance

Job Description

PRIMARY ACTIVITIES                                                                        

Primary activities include, but are not limited to:

Complaint Management:

• Supports the Complaint Management Topic ensuring all product quality complaints (PQC) are investigated within the specified timeframes and Corrective and Preventive Actions are identified when required.

• Assess whether reporting to Health Authority is required.

• Performs trending to identify any specific or recurring problems.

• Approves low and medium risks complaint investigations.

Management Review of Medical Devices and Combination Products:

• Supports / executes the Management Review of Medical Devices and Combination Products at the Wilson site including the Quarterly Tracking and Trending and the Annual Management Review.

Other responsibilities:

• Manages Deviations and Investigational activities.

• Manages Change Controls.

• Supports the annual product review process.

• Proactively monitors trends and recommends corrective actions to cease performance issues.

• Participates in Internal and external GMP audits and inspections.

• Interprets our Company Quality policies, GMP's and other agency regulations for application to Wilson Operations. Also, mentor others in these decisions.

• Challenges technical support and production groups to ensure robust root cause analysis and identification of corrective actions. Able to present data to others outside of working group to gain consensus on appropriate path forward.

• Provides Quality Assurance review of all GMP-related SOPs.

• Participates on programs/procedures to improve compliance status of Wilson operations, including investigations and GMP audits.

• Participates on the implementation of new programs/regulations/divisional processes at the site.  

• Identifies continuous improvement opportunities (business and compliance excellence) through the use of lean six sigma methodology and identification of improvement opportunities.

• Participates on divisional/site teams focused on improvement.     

• Demonstrate leadership by maintaining a safe workplace and identifying actions to prevent safety incidents.

Education Requirements:

• High School Diploma considered with minimum of 2 years of experience in quality assurance or pharmaceutical industry.

• Bachelor's degree preferred.

Required Skills:

• Possesses a basic knowledge of theories, practices, and procedures in the Quality Assurance discipline, including the knowledge and understanding of pharmaceutical operations systems.

• Ability to perform routine assignments and develops competence by performing structured work assignments. 

• Ability to use existing procedures to solve routine and standard problems. 

• Receives instruction, guidance, and direction from others and also seeks advice/information from others when addressing serious business issues.

• Promotes the team’s effectiveness through actions that demonstrate respect and appreciation for diverse perspectives. 

• Speaks up on tough issues and expresses views and ideas at the right time while actively encouraging team members to make suggestions and share ideas.

• Works to develop new skills and abilities.

• Readily accepts performance feedback and incorporates this feedback into future performance.  Assists other team members, including helping with developmental activities.

• Learns to use new problem solving tools to solve issues.

• Ability to interpret our Company Quality Policies, Procedures and Guidelines for daily application.  Developing technical writing capabilities and is able to compile straightforward investigations and procedures. 

• Ability to independently respond to basic requests for data and trending of data.

Preferred Skills

• Leverages of IT tools to drive efficiencies and solve complex problems.

• Ability to learn new processes and computerized systems with limited support.

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