Vegas - Quality Investigations Specialist

Summary

About the job

Assists with compliance activities and continuous quality improvements. Responsible for the accumulation and generation of investigation materials and reports. Acts as a liaison between the Quality Investigations Supervisor and Quality Investigations team. Shares responsibility for Investigation training and guidance of the Investigations team.

Key Responsibilities

• Conducts and/or assists with complaint investigations as needed.
• Conduct and assist in review of EVENT, NONC, DEV, and CAPA records.
• Gathers information, investigates, and documents deviations, EVENT, NONC, and CAPA.
• Assists with trending of deviations, EVENT, NONC, and CAPA.
• Assists with APR's.
• Organize and coordinate the timely completion of regulatory records.
• Participates in quality management meetings and other initiatives.
• Assists with the auditing of current Standard Operating Procedures (SOPs).
• Understands the principles of cGMP, GDP, and HIPAA.
• Other duties may be assigned.

Set yourself apart

Basic Qualifications

• At least five years of related experience and/or training.
• Active/current Pharmacy Technician License required. Registration(s) required by state in which pharmacy is located.
• High attention to detail is required.
• Computer literacy, including but not limited to, Windows, Office 365 Suites, and Microsoft Teams.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. The ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to apply mathematical operations to such tasks as sampling theory and factor analysis.

Working Conditions

• This position requires standing and sitting for extended periods of time including majority of shifts. Walking, kneeling and bending frequently.
• Employees will be required to lift and carry up to 50 pounds.
• Employees will be required to read small print.
• Employees will be required to don Gown and PPE.
• Employees will be required to handle hazardous drugs as outlines in NIOSH, including spill cleanup with proper PPE when required.
• While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of radiation. The noise level in the work environment is usually moderate.

What's on offer?

At AnazaoHealth, you'll find plenty of opportunities to grow and make an impact. We offer competitive pay, a comprehensive benefits package (including 401k and Volunteer Paid Time Off), and a supportive workplace where your ideas and talents can shine.

We're proud to be an Equal Opportunity Employer and maintain a drug-free workplace. Diversity makes us stronger, and we're committed to building an inclusive environment where everyone feels welcome.

Job Description

About the job

Assists with compliance activities and continuous quality improvements. Responsible for the accumulation and generation of investigation materials and reports. Acts as a liaison between the Quality Investigations Supervisor and Quality Investigations team. Shares responsibility for Investigation training and guidance of the Investigations team.

Key Responsibilities

• Conducts and/or assists with complaint investigations as needed.
• Conduct and assist in review of EVENT, NONC, DEV, and CAPA records.
• Gathers information, investigates, and documents deviations, EVENT, NONC, and CAPA.
• Assists with trending of deviations, EVENT, NONC, and CAPA.
• Assists with APR's.
• Organize and coordinate the timely completion of regulatory records.
• Participates in quality management meetings and other initiatives.
• Assists with the auditing of current Standard Operating Procedures (SOPs).
• Understands the principles of cGMP, GDP, and HIPAA.
• Other duties may be assigned.

Set yourself apart

Basic Qualifications

• At least five years of related experience and/or training.
• Active/current Pharmacy Technician License required. Registration(s) required by state in which pharmacy is located.
• High attention to detail is required.
• Computer literacy, including but not limited to, Windows, Office 365 Suites, and Microsoft Teams.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. The ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to apply mathematical operations to such tasks as sampling theory and factor analysis.

Working Conditions

• This position requires standing and sitting for extended periods of time including majority of shifts. Walking, kneeling and bending frequently.
• Employees will be required to lift and carry up to 50 pounds.
• Employees will be required to read small print.
• Employees will be required to don Gown and PPE.
• Employees will be required to handle hazardous drugs as outlines in NIOSH, including spill cleanup with proper PPE when required.
• While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles, toxic or caustic chemicals, and risk of radiation. The noise level in the work environment is usually moderate.

What's on offer?

At AnazaoHealth, you'll find plenty of opportunities to grow and make an impact. We offer competitive pay, a comprehensive benefits package (including 401k and Volunteer Paid Time Off), and a supportive workplace where your ideas and talents can shine.

We're proud to be an Equal Opportunity Employer and maintain a drug-free workplace. Diversity makes us stronger, and we're committed to building an inclusive environment where everyone feels welcome.