Job Opening for Quality Assurance Officer at Avella Speciality Pharmacy

Quality Assurance Officer
Avella Specialty Pharmacy - Phoenix, AZ

POSITION SUMMARY
The Quality Assurance Officer ensures that all processes contributing to the performance of the company quality programs are in accordance with company policies and relevant regulations.
Supervise and guide the activities of the quality assurance department staff. Review, revise, or develop and establish a quality program that includes; review or revision of policies that affect processes in the Pharmacy Compounding, Mail Order, Retail Pharmacy and Wholesale businesses. Oversee the Internal Audit Program for review of the various quality processes in these businesses to ensure compliance with company and regulatory standards. Coordinate with business leaders to assist in their implementation of improved quality systems or processes. Provide senior management quality trend information and keep them informed of major quality issues. Respond to business leaders needing assistance with their quality control programs.
SUPERVISORY RESPONSIBILITIES
Sr. QA Manager
ESSENTIAL DUTIES AND RESPONSIBILITIES

• Develop and implement standard operating policies and procedures
• Oversee the company’s accreditation
• Implement the company wide quality system
• Develop a training program for all aspects of the quality system
• Own the Complaint Process (track complaints, investigations, and CAPA follow thru)
• Management of Non-Conforming Material Management: Investigations, CAPA, and

Disposition

• Development of: Quality Policies, SOPs, Work Instructions, or Forms
• Review Company Calibration, Environmental Monitoring, and Pest Control Programs

for compliance to good manufacturing or business practices, and revise as needed.

• Monitor and Audit the quality systems for compliance to established standards
• Work with business leaders to implement continuous improvements
• Report Metrics of the quality system to Executive Committee
• Manages budget and allocates resources accordingly.
• Work collaboratively with internal/external groups to achieve business results.
• Work collaboratively with others to implement change to achieve business results.

KNOWLEDGE, SKILLS AND ABILITIES

• Bring a strong industry operational background
• Strong verbal & written communications skills and organization skills
• Decision making ability to maintain compliance with rules and regulations
• A self-starter requiring minimal supervision for day-to-day tasks and ability to lead/work

in partnership with cross-functional teams to achieve goals & objectives

• Strong problem solving & analytical skills, ability to maintain current on related quality

and compliance issues (State/Federal)

• Demonstrated teamwork skills
• Demonstrated ability to initiate and implement change.
• The ability to organize and manage multiple priorities.
• Ability to work accurately in a fast paced environment
• Ability to communicate technical information to non-technical personnel.
• Commitment to company values and the ability to be a strong team player
• Ability to assign, prioritize, and evaluate the work of others
• Must possess a professional appearance and possess excellent communication skills

EDUCATION AND/OR EXPERIENCE

• Minimum of 5 years of hands on Quality Systems Program Development and

Management to include: GMP, GLP, ISO, and FDA compliance required.

• Prior experience with employee training, customer service support and regulatory

compliance required.

• Prior experience designing and performing internal and external audits
• Quality Systems Regulatory Compliance experience
• Demonstrated experience with Validation Programs (equipment/environmental)
• Prior experience with new product launch activities such as Standard Operating

Procedure initiation, training and product transfers.

• Prior demonstrated experience leading teams to include, development, goal setting,

and compliance with continuous quality improvement programs

• Prior experience managing and meeting department budgets
• Prior experience with document control and document archive systems and change

management
CERTIFICATIONS, LICENSES, AND REGISTRATIONS
None
PHYSICAL DEMANDS AND WORK ENVIRONMENT
The physical demands and work environment are characteristic of those found in a typical pharmacy environment. Reasonable accommodations may be made for individuals with disabilities to perform essential functions.
JOB DESCRIPTION STATUS
The duties and responsibilities listed in this job description are illustrative ones anticipated for this position. Other duties and responsibilities may be assigned, as required. Avella reserves the right to amend or change this job description to meet the needs of the program. This job description and any attachments do not constitute or represent a contract.
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