Scientist, Quality Control Cover Letter

I would like to submit my application for the scientist, quality control opening. Please accept this letter and the attached resume.

In the previous role, I was responsible for scientific and operational leadership in the areas of cGMP-compliant biopharmaceutical testing services that include protein characterization and release testing.

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:

• Possesses a thorough knowledge of quality systems
• Superior abilities relevant to the laboratory
• Exhibits expertise in analytical areas
• High level of technical training
• Experience coordinating or executing viral clearance studies
• Knowledge of Downstream Purification (Column Chromatography, Viral Filtration, Inactivation) methods utilized in viral clearance and virology methods used to assess clearance
• Knowledge of FDA/EMA/JP regulations
• Experience with the following instrumentation (Ion Torrent, Next Generation Sequencing, qPCR, HPLC, HPIC, Quantstudio, Liquid Gas Chromatography, Mass Spectroscopy, Gel Imager, etc

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

In my previous role, I was responsible for information for Product Development, the dissolution testing of Company and competitor products, the physical characterization of drug substances, excipients and dosage forms.

My experience is an excellent fit for the list of requirements in this job:

• Analysis of cGMP samples utilizing various analytical techniques-HPLC, dissolution, GC, KF, , including method validation and method transfer
• Demonstrated knowledge with both drug substance and drug product (oral solid dosage forms) testing
• Proficient with electronic notebooks and computerized Quality Management Systems
• Knowledge of Empower Software
• Knowledge of Compendia such as USP, NF, EP and FCC is preferred
• Preferred experience with FDA regulated industry
• Strong knowledge of sterility lab equipment and supporting laboratory equipment
• Isolate and maintain cultures of bacteria or other microorganisms such as algae, fungi, and some types of parasites, of both pathogenic and non-pathogenic abilities

I would like to submit my application for the scientist, quality control opening. Please accept this letter and the attached resume.

Previously, I was responsible for information for Product Development, the dissolution testing of competitor products, the physical characterization of drug substances, excipients, and dosage forms.

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:

• Experience in a cGMP environment managing samples, ensuring chain of custody, accuracy, and compliance
• Prior experience with facility construction or laboratory start-up strongly preferred
• MDI/DPI testing experience is highly desirable
• Quality control experience is desirable
• Enjoy working in the laboratory
• Experience in HPLC, GC and other analytical techniques
• Working knowledge of mass spectrometry is desirable
• Oversee the procurement of bulk quantities of antibodies and other critical reagents and oversee their analytical and performance testing and subsequent release according to established reagent and clinical assay specifications

I am excited to be applying for the position of scientist, quality control. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for phone and on-site post-sales technical and application support to Agilent's UV-Vis-NIR, FTIR, Fluorescence, Raman and Imaging user base.

Please consider my qualifications and experience:

• Oversee the production and release of custom assay control and proficiency specimens
• Maintain a large inventory of assay critical reagents and associated electronic database
• Oversee the distribution of assay critical reagents to external and internal laboratories
• Supervise research associates in performing all laboratory operations, associated procurement and QC reporting activities
• Demonstrated experience in antibody analytical and performance characterizations
• Experience in supervising laboratory staff from the entry technician level through associate scientist level bench scientists
• Partner with Corporate Compliance, Quality Assurance, Global Information Services, and Operations-Facilities in execution of QC functions
• Review of technical and compliant cGMP analytical data

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

In the previous role, I was responsible for technical direction within own area of expertise (GC) within the team whilst independently performing a range of GMP analyses by GC including method development / optimization and validation.

Please consider my qualifications and experience:

• Recording, analyzing and interpreting data, while ensuring that data is recorded accurately in accordance to guidelines
• Conducting microbiological tests and inspections of products, services, or processes to evaluate quality or performance
• Experience working with Microbes and Bacteria and associated knowledge of a biosafety level 2 laboratory
• Knowledge of Microbiology and Biochemistry as they relate to bacteria, yeast, and fungi
• Knowledge of the following industry regulations FDA (Food and Drug Administration), GMP (Good Manufacturing Practice) / QSR (Quality System Regulation), ISO (International Organization of Standardization)
• Knowledge of cGMP (Good Manufacturing Practice) and In-depth understanding of good documentation practices in a GMP environment
• Multi-level profile access to SAP Quality module is preferred
• Quality systems experience is highly preferred