QC Microbiology Cover Letter

I am excited to be applying for the position of QC microbiology. Please accept this letter and the attached resume as my interest in this position.

Previously, I was responsible for the required level of management to deploy team resources to maintain agreed testing schedules, control bottleneck processes and resolved operational constraints to improve productivity and flexibility within QC.

Please consider my experience and qualifications for this position:

• Experience with environmental monitoring, sampling and testing is preferred
• Demonstrated knowledge of USP methods is preferred
• Basic knowledge and exposure with a LIMS, ERP system is preferred
• CGMP, USP, EU
• Regulated Manufacturing
• Advanced knowledge of current Good Manufacturing Procedures (cGMP), USP, EU and other global regulatory requirements
• Advanced knowledge of OSHA and DEA
• Advanced MS Word, Outlook, Excel, MS PowerPoint, Visio

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

Previously, I was responsible for site specific LIMS application support, problem reporting and resolution SME for Sample Management supporting quality events.

Please consider my qualifications and experience:

• Advanced knowledge in microbiology and/or in environmental/utility monitoring
• Knowledge in GMP or other quality systems
• Experience with pharmaceutical production or food industry will be beneficial
• Able to work effectively, independently and within a team framework, across all business areas and levels of the organization
• Familiarity with electronic databases (preferred)
• Manage all network support activities and ensure they are delivered on time and within budget
• Management of the Quality control team ensuring adherence to the highest standards
• Managing schedules and targets to meet regulatory and business requirements

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

Previously, I was responsible for support for cGMP and GLP release and stability testing of preclinical and clinical therapeutic protein samples.

Please consider my qualifications and experience:

• Strong critical reasoning and decision making
• Strong teamwork and facilitation skills
• Able to develop and motivate others delegate and solve routine problems
• Environment with cGMP requirements
• Experienced understanding of cGMPs and other regulatory guidelines applicable to the pharmaceutical industry
• Advanced quality understanding and knowledge of the current technical analytical requirements from pharmacopoeia (USP, Ph.Eur) and knowledge of the relevant guidelines (FDA, EU, PICIS, ICH)
• Assists in development, implementation and maintenance of general laboratory operational systems in accordance with cGMP requirements
• Troubleshoots issues related to laboratory procedures and assay performance

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

Previously, I was responsible for superlative service to client by performing duties accurately and within the expected time frame under minimal supervision following GMP.

Please consider my qualifications and experience:

• Provides support to audit teams for internal and vendor audits
• Experience with rapid microbiology methods (preferred)
• Demonstrated compliant behaviors in a regulated manufacturing environment
• BS Microbiology, Biotechnology, Molecular Biology
• Microbiology lab experience strongly preferred
• High knowledge in microbiology, aseptic practices and associated regulations (Eudralex, FDA & CFR, PICs…)
• Good understanding of pharma industry microbiological testing (Bioburden, Sterility, Endotoxins, Disinfectant efficacy, Mycoplasma…) and Environmental Monitoring
• Good knowledge in microbiology test validation principles

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

In the previous role, I was responsible for valuable problem solving and project management abilities to lead or participate in continuous improvements in product quality, cGMP compliance and the quality management system.

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:

• Managing the validation/qualification of Microbiology test methods and test systems to support in process and commercial release testing
• Manage the implementation of a paperless lab (SDMS & LIMS)
• Manage QC inspection readiness for all inspections and represent the QC in audits and inspections
• Lead the sterility assurance program for the facility with the QC and manufacturing team to implement and maintain a robust aseptic processing and monitoring program
• Provide SME support to the Manufacturing and Projects teams (inclusive of NPI projects for commercial product and new builds) which the company undertakes through project participation and QC readiness
• Represent QC at product and technical team meetings and lead/drive all associated support activities
• Support the training strategy for QC, managing the development, operation and evaluation of training/re-training programs
• Lead the tiered communication process for scheduling of tasks in QC to support commercial operations and prioritization