Compounding Cover Letter

In response to your job posting for compounding, I am including this letter and my resume for your review.

In the previous role, I was responsible for day-to-day technical support to Compounding units including guidance to team members; leading problem solving processes and root cause analyses.

Please consider my qualifications and experience:

• High School Diploma or GED (High School Equivalent) is preferred
• Basic Math Skills for the accurate checking and adding of materials
• Previous relevant experience in a manufacturing environment
• Knowledge of medical devices or pharmaceutical GMP rules
• Knowledge of plant, equipment and processes
• Experience of managing and controlling budgets
• Previous experience of establishing KPI’s and measures within a maintenance function
• Knowledge of Health, Safety and Environment legislation

In response to your job posting for compounding, I am including this letter and my resume for your review.

In the previous role, I was responsible for routine, ongoing evaluation of equipment and products utilized in sterile compounding practices.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Quality System management and implementation
• Audit preparation, hosting, follow-up
• Front-end exposure to HPRA, MHRA inspections
• Communication to HPRA, MHRA
• Sterile Aseptic Manufacturing
• Environmental / Microbiological control
• Isolator Technology
• Ensure compliance with all safety/health related policies and procedures, participate in company sponsored safety programs and activities, and report to management those conditions or actions by employees or others that might create a hazard to themselves or others in the plant

I would like to submit my application for the compounding opening. Please accept this letter and the attached resume.

Previously, I was responsible for a standardized Perfect Equipment system across the Lund Compounding Unit in collaboration with local operational staff, Operations Manager, EMEA Engineering team and the Head of Engineering.

Please consider my qualifications and experience:

• Experience of driving organisational change
• Experience in a clean room environment and best practices
• Strong technical background, ideally in extrusion processes (compounding, melt filtration, optical sorting)
• Experience in toller management
• Developed leadership, influencing and communication skills, combined with a pragmatic approach (80/20)
• Ensures compliance with USP <797>, <795> and <800> federal standards
• Provides in-services education to pharmacy staff, nurses, physicians and other departments as requested and/or assigned
• Participates in hospital and departmental quality assurance activities related to product preparation environment

I submit this application to express my sincere interest in the compounding position.

Previously, I was responsible for expertise on manufacturing capabilities, and support implementation of new products in manufacturing (e.g, scaling up new products, proper compounding processing window).

Please consider my experience and qualifications for this position:

• Coordinate and monitor environmental and personnel testing and coordinate action plans related to results as appropriate
• Provide interface and liaison to regulatory agencies
• Oversight of technicians working in the IV room
• Provide constructive feedback to technicians in IV room about performance
• Track IV room waste and make changes to production to minimize waste
• Work with other departments to coordinate services as it relates to the Sterile Compounding Suite
• Perform Environmental Monitoring, surface sampling, employee aseptic competencies
• Develop and maintain department standard operating procedures, Beyond Use Dating and Assessment of Risk as it relates to USP <797>, <795> and <800> standards

Please consider me for the compounding opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for a standardised Perfect Equipment system across the Compounding Unit in collaboration with local operational staff and the EMEA Engineering Manager.

Please consider my experience and qualifications for this position:

• Plans and prioritizes work to meet commitments aligned with organizational goals
• Holds self and others accountable to meet commitments
• Process safety responsibility and high level of engagement on safety programs
• Compounding/Extrusion experience
• Working knowledge of SPC and Minitab software
• Knowledge of cGMP manufacturing preferably pharmaceutical manufacturing
• Office and production floor environment
• Executes specialized responsibilities mandated by detailed written procedures, site, industry