Who we are
At AnazaoHealth, we’re all about creating personalized medications that truly make a difference. As a specialty compounding pharmacy, we serve the pain management markets, provide drugs for clinical trials, and support wellness with tailored solutions.
With pharmacies in Tampa, Las Vegas, New Jersey, and San Diego, our teams are dedicated to improving lives through innovation, quality, and care.
We’re growing fast and looking for passionate people to join us on our journey.
About the job
Independently responsible for the efficient and thorough investigation of process deviations, determination of root cause, and initiation of corrective/preventative actions designed to adequately address and correct the Quality related deficiencies identified during the investigation process.
As part of each investigation, gathers information from all necessary internal and external sources in order to evaluate the impact of the deviation on previously manufactured product, as well as the risk to future operations.
Prepares and analyzes historical data and uses methodical root-cause analysis tools to determine and effectively communicate root causes.
Responsible for ensuring compliance with relevant Standard Operating Procedures, while gathering, analyzing and applying information from internal and external sources in order to perform a risk assessment of the impact each process deviation has on the product, process, and patient health and safety.
Responsible to provide proactive corrections based on noted trends to minimize the potential for repeat incidents that may lead to, or result in, impact to product or patient/operator safety.
Provides technical expertise to the site to ensure that investigation corrective and preventative actions are complete, thorough, accurate, and timely.
Updates and maintains all related quality management systems in compliance with various governing procedures and policies as they relate to investigations and performs trend analysis.
Works independently to comply with procedure driven guidelines relating to Deviation and complaint investigations and makes decisions that directly affect patient health and safety.
Demonstrates strong technical skills; provides technical assistance to area supervisors or managers to solve complex problems.
Ensures that deadlines are maintained and closely monitors the need for extensions to be administered in relation to Subsequent Actions and Investigations in order to maintain compliance in this area.
Perform any other tasks/duties as assigned by Manufacturing Management.
Comply with all state and federal regulatory requirements and guidelines
Ensure security of Protected Health Information as per HIPAA requirement
Set yourself apart
You possess the following qualifications, background and abilities:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor’s degree in science or engineering and 2+ years related experience and/or training or experience in the pharmaceutical manufacturing environment GMP related to production, engineering, project management, and/or validation preferred. Must be familiar with regulatory (FDA) requirements.
LANGUAGE SKILLS
Advanced writing skills including experience with root cause analysis tools. Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of employees within the organization. Strong interpersonal, written and verbal communication skills.
MATHEMATICAL SKILLS
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs Able to analyze data and provide statistical analysis. Ability to use a computer for day-to-day work applications.
REASONING ABILITY
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations. Ability to draw conclusions and inferences from abstract information.
CERTIFICATES, LICENSES, REGISTRATIONS
None
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee frequently is required to sit; stoop, kneel, crouch, or crawl; and talk or hear. The employee is occasionally required to taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust focus.
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.
Ready for the challenge?
Take the next step and join us in shaping the future of personalized medicine. Apply online today and don’t forget to include your salary requirements.
No phone calls, please.
We do not accept agency referrals for this position.
Job Reference: NA00508
