Quality Assurance Specialist

FULL JOB DESCRIPTION - QUALITY SPECIALIST Akina Pharmacy is a 503A Compounding Pharmacy dedicated to providing our customers with uncompromising quality, reliability, and service in meeting their compounded sterile and non-sterile pharmaceutical product needs. Our employees enjoy a work culture that promotes innovation, integrity, honesty, accountability, fairness, and fun. We are seeking a highly motivated self-starter to join our company as a full-time Quality Specialist. This position is responsible for assisting the Director of Quality and Director of Quality in the implementation and management of the Quality Department. The Quality Specialist is also responsible for testing, observing processes, gathering and analyzing data related to quality measures, investigating quality issues, assisting in the performance of root cause analyses, identifying training needs, and organizing training interventions to meet quality standards. This position organizes the data gathered in a meaningful way to interpret results and create initiatives. REQUIRED EDUCATION AND EXPERIENCE:

Bachelor of Science in Biology, Microbiology, Chemistry, Toxicology, Nursing, Clinical Laboratory Science, or related field required; master's degree preferred

Training and experience in quality or performance improvement strongly preferred with quality assurance or quality control experience required

Clinical, industrial, or analytical processes troubleshooting experience strongly preferred

cGMP, USP , or pharmaceutical compounding facility experience preferred

ESSENTIAL DUTIES AND RESPONSIBILITIES: Works closely with the Director of Quality, and may at times, carry out those duties which include, but are not limited to:

Performs testing, including Environmental Monitoring, Air and Surface Sampling or other testing, as needed

Assists in performing employee competency checks including, garbing, hand hygiene, fingertip, and bubble pointing tests as needed

Performs reviews of equipment maintenance, validations, and other reviews as necessary

Understands and follows cleaning and disinfection procedures for all work areas

Assists in the media fill process validations to include inspection of filled units

Ensures personnel compliance with all quality programs

Informs management of critical compliance, regulatory or process findings or observations which may negatively impact quality assurance

OTHER DUTIES AND RESPONSIBILITIES:

Observes processes including, but not limited to, cleaning and environmental monitoring testing

Performs Root Cause Analysis assignments including the investigation, research, analysis, and documentation of the assignment

Creates and implements performance improvement initiatives

Completes thorough documentation of all assignments, including, but not limited to, testing, monitoring, sampling, observations, competencies, analyses, inspections, reviews, and initiatives related to quality control

Works with the Director of Quality to continuously improve the quality program by evaluating supporting documentation to ensure compliance with cGMP, USP , industry standards, and other applicable regulations

Communicates and interprets quality guidelines effectively with coworkers and customers

Participates on project teams and provides necessary support to meet required deadlines, working with teams and partnering to facilitate continuous improvement

Reviews records, performs internal audits, desk audits, and recommends corrective action

Performs routine trend analysis, compiles information, and develops reports, as assigned

Provides training to all personnel to ensure all quality initiatives are properly understood and followed

Submits samples to the appropriate lab for testing and analysis

Maintains quality records

(equipment calibration and maintenance, training, deviation and compliant investigation, environmental monitoring, Certificate of Analysis, clean room certifications, etc)

Writes, distributes, and maintains quality policies related to operations and production

Reviews the implementation and efficiency of quality systems

Serves as a resource to operations regarding equipment and facility validations, calibrations, and unexpected events

Serves as a liaison to Information Systems to facilitate innovation and continuous improvements in Quality Management Systems development

Works closely with the Quality Coordinator, under the direction of the Quality Manager

Recognizes patients' rights and responsibilities and supports them in the performance of job duties; respects patient's rights to privacy and confidentiality

Completes assigned paperwork/documents as directed in a timely manner

Shares knowledge gained with other staff members and works as a team member

Interacts with others in a positive, respectful, and considerate manner

Performs other job related duties, as assigned

POSITION ADVANCEMENT REQUIREMENTS:

Required t