Specialist Manufacturing Cover Letter

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

Previously, I was responsible for oversight of quality management system activities including Preventive Maintenance, Deviation Management and the Change Control Programs.

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:

• Work environment includes plant, warehouse, and plant grounds
• Excellent written (especially technical writing) and verbal communication skills
• Superior planning, time management and coordination skills and be able to readily adapt to changes in priorities and project schedules
• Attention to detail and good investigation, problem solving and organizational skills
• Familiarity with SAP system an advantage
• Large-scale microbial fermentation and mammalian cell culture processes with associated recovery processes is essential
• Sound background in equipment qualification is essential
• Wearing clean room garments (bunny suit) is necessary to protect hair, dry skin, from contaminating the product (wafers)

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

In my previous role, I was responsible for quality support to Quality Control personnel on the floor; provide guidance during GMP events and initiation of deviation investigations.

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 working with CMO’s
• Hands on purification experience with cGMP clinical and commercial manufacturing
• Familiarity with perfusion bioreactor systems coupled with ATF and other harvesting technologies such as direct capture and continuous manufacturing
• Knowledge of downstream cGMP manufacturing of recombinant enzymes
• Extensive experience with electronic documentation systems in a regulated environment
• Experience in GMP operations
• Technical knowledge of biotechnology cell culture and drug substance purification operations
• Experience validating computer based systems

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

Previously, I was responsible for subject matter expertise to SOP, nonconformance, investigations, corrective and preventive actions, change control records or validations.

Please consider my experience and qualifications for this position:

• Able to follow directions and instructions precisely
• High interest in expanding manufacturing skills into other hardline and soft line categories
• Strong knowledge of MS Word, Excel and other Office software
• Broad technical knowledge of GMP systems and experience
• Understand manufacturing processes and quality systems
• Computer skills, , Microsoft office, electronic documentation system, ERP systems
• Acted as an SME preferably at a CMO supporting the functions listed above either in quality and/or manufacturing
• Good logical-reasoning, verbal and written communication skills

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

Previously, I was responsible for oversight and guidance to sustain compliance with Regulatory, Corporate and Site GMP processes for Engineering documentation, which includes all change controls, validation, com-missioning, deviation, SOPs, capital project files, and drawing, documents.

Please consider my experience and qualifications for this position:

• Intermediate knowledge of cGMP for a controlled manufacturing area
• Proficient in project management responsibilities
• Superior organizational and multitasking abilities
• Knowledge and familiarity with engineering design and manufacturing tools
• Excellent organizational and decision making skills with a result driven approach
• Gains understanding from provided instructions and works toward goals with minimal supervision
• Understands and listens to team members and stakeholders needs while supporting productive team environments toward a common objective
• Experience in collaborating with CMOs/CROs is preferred

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

Previously, I was responsible for tracking and trending of compliance activities (ex, change controls, investigations, corrective and preventive actions).

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:

• Good communication, organization, computer, interpersonal, coaching and facilitation skills
• Self-confident, results orientated individual with excellent technical skills
• Knowledge and understanding of consumer trends in lifestyle brand fashion is highly desirable
• Expert in cell culture (USP), bioreactors, virus propagation and downstream processing (DSP)
• Certified Lean Yellow Belt, preferably Green Belt
• Fluency in downstream process design and operations is essential (i.e., column packing, chromatography skid preparation/operation, TFF preparation/operation)
• Engages in and supports a culture of continual improvement
• Solid working knowledge of manufacturing methodologies and principles