i

Quality Control Sterility Core Analyst II Resume Sample


Complete Name
Complete Address
Phone # / Cell Phone #
E-mail Address

QC Sterility Core Analyst II

QUALIFICATIONS PROFILE

Highly analytical, dynamic, and competent professional offering broad-based experience in the area of biotechnology and QC testing complemented with strong educational foundation. Committed to applying state-of-the-art concepts to reduce costs while optimizing operational efficiency, process, and productivity. Continuously thrive in achieving the integrity of products, their safe manufacture, and distribution while ensuring compliance with standards and regulatory requirements. Dedicated to provide customers with exceptional products and services while fulfilling customer needs and expectations. Possess a keen eye for detail with proven ability to multitask in challenging, stressful, and fast-paced environment. Willing to relocate in Richmond, Virginia.

CORE STRENGTHS

  • Lean Manufacturing and Six Sigma Techniques
  • Quality Assurance and Industry Best Practices
  • Continuous Process and Performance Improvement
  • BacT Alert 3D Microbial Detection System
  • USP Sterility Testing and Validation
  • Competitive Research and Analysis
  • Aseptic Technique and Cleanroom Environments
  • Leadership, Training, and Team Building
  • Problem Resolution and Decision Making
  • Superior Interpersonal and Presentation Skills

EMPLOYMENT HISTORY

QC STERILITY CORE ANALYST II | LONZA, WALKERSVILLE, MD | 2006–PRESENT

Evaluate sterility samples in a class 100/ISO 5 cleanroom environment and laminar flow biological safety cabinets to consistently maintain >99.5% on-time testing metric. Compile informative data and organize records to ensure compliance with regulatory requirements (USP and EP) and standard operating procedures (SOPs). Adhere strict compliance with basic scientific principles, procedures, and theories in analyzing products. Assume full responsibility in maintaining laboratory cleanliness, order, and stocks of supplies. Train newly hired and members of other departments to develop their competencies in sterility testing techniques and procedures. Regularly interface with clients and co-workers and singlehandedly schedule activities to meet clients’ diverse needs.

Notable Achievements:

  • Carried out all bacteriostasis and fungistasis validation testing as necessary on USP products
  • Prepared monthly reports to the management to measure all notable contributions done within the laboratory
  • Received two “MVP Awards” by fostering a positive working environment and team unity to staff
  • Appointed to be the 5S (Lean Six Sigma) initiative team leader for the department; vigorously attended meetings to discuss 5S and supported the team to achieve the 5S (sort, store, standardize, shine, and sustain); implemented Operational Excellence 5S ideas in QC Sterility/Mycoplasma departments for continuous improvement of systems and processes
  • Incurred $2K annual savings for supplies by redesigning an environmental monitoring
  • Played a vital role in revising paperwork for validation testing resulting in annual savings of 37.5 man-hours
  • Significantly improved workflow through the creation of new forms and SOPs
  • Commended as a key player for displaying quick-learning and critical-thinking skills in the qualification, implementation, and validation of MODA (Mobile Online Data Acquisition), a paperless environmental monitoring system in the Sterility cleanroom
  • Solely analyzed turnaround-time for an outsourced test and found evidence to lengthen by 9 days
  • Facilitated cross-training on the following to gain knowledge of the company and lend assistance to other departments:
    • QC Microbiology: Gram stain, colony morphology, aseptic process validation screening, growth promotion qualification for liquid and solid growth media, and water bioburden testing
    • QC Mycoplasma: Vero cell maintenance, test initiation, and subculture, MycoAlert testing

CHILDREN’S DEPARTMENT ASSOCIATE | KOHL’S DEPARTMENT STORE, FREDERICK, MD | 2001–2006

Courteously welcomed and assisted customers in finding merchandise by directing them to the location or by checking the stockroom or calling other stores. Rendered high level of support to the register as necessary. Primarily held responsible for maintaining supplies of merchandise for customer convenience.

Notable Achievements:

  • Ensured compliance with written procedures to effectively adjust quarterly floor plan to corporate layout
  • Pivotal in maintaining rack integrity for an easier shopping experience

BIOLOGY EXPERIENCE

RESEARCH ASSISTANT | LEBANON VALLEY COLLEGE BIOLOGY DEPARTMENT, ANNVILLE, PA | 2003–2005

  • Executed agarose gel electrophoresis, PCR reactions, gene cloning, and bacterial transformations resulting in research poster display at the 2003 and 2004 Pennsylvania Academy of Science meetings

INTERN | UNIVERSITY OF DELAWARE COLLEGE OF MARINE STUDIES, NEWARK, DE | 2003

  • Tasked to collect specimens from salt marsh tidal lands
  • Completed situ staining, slide mounting of specimens for photographing, polyacrylamide gel electrophoresis, Western blots, and PCR in a Hox gene study

EDUCATION

MASTER OF SCIENCE IN ENVIRONMENTAL BIOLOGY, GPA: 3.45/4.0

  • Hood College, Frederick, MD: 2007–2011

Coursework: Environmental Biology, Principles of Ecology, Conservation Biology, Natural Resource Management, Geographic Information Systems, Landscape Ecology, Pollution Biology, Biostatistics, Marine Ecology, Research Design and Analysis
Thesis: “Determining Pennsylvania Area-Sensitive Forest Bird Species and Using GIS to Designate Critical Forest Habitat”

BACHELOR OF SCIENCE IN BIOLOGY, GPA: 3.17/4.0

  • Lebanon Valley College, Annville, PA: 2002–2006

Beta Beta Beta Biological Honor Society Member: Spring 2006

TECHNICAL PROFICIENCY

MS Office Software: Word, Excel, PowerPoint, and Access | SAP| RenCS | NovaManage| SPSS software | ArcView GIS
Typing speed of 80 words per minute

 

 

Leave A Comment

resume writing services for all careers