QC Scientist II

Job Description

Job Description

Job Title:QC Scientist IIJob Location: Greenville, NC

Duration: 12 Months

Shift Schedule:

1st Shift, 8-5pm

The QC Scientist II provides moderately complex analyses in a microbiology lab environment within defined procedures and practices. Performs analytical methods for moderately complex testing on raw materials, samples, stability, and production intermediates. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results; recommends solutions.

• Conducts moderately complex microbiological testing of in-process products and finished products by internally developed and compendial test methods.
• Executes validated test methods for in-process products and finished products for Bioburden, Bacterial Endotoxin Testing, Particulate Matter, Sterility, and Water testing.
• Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems; recommends solutions.
• Maintains and troubleshoots analytical instrumentation as needed.
• Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results.
• Records and reports results of analysis in accordance with prescribed lab procedures and systems. May interact with clients.
• Prepares and assists in filing regulatory documents in support of internal projects. Provides communications with outside departments, corporate sites, agencies, and clients.
• Writes SOPs and other instructional documents.
• Cleans and organizes work area, instrumentation, and testing materials. Maintains stock of commodities needed for testing support.
• Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.

• Bachelor’s degree in Biology or Chemistry preferred. An Associate degree preferably in Biotechnology or science concentration is minimally required and with this degree, industry experience will be considered.
• 3 years related experience in a Pharmaceutical Microbiology laboratory or related experience. Good knowledge and understanding of chemistry and analytical instrumental technologies.
• Experience with LIMS, SLIM, Trackwise, or Documentum a plus. Experience as a reviewer approver or qualified checker preferred.
• Highly organized, detail-oriented, and self-motivated.
• Adaptable and capable of working within a team as well as independently.
• Knowledge and understanding of the scientific approach to microbiological methods development and validation.
• Knowledge of qualitative and quantitative microbiological tests.
• Awareness of quality and regulatory requirements in the pharmaceutical industry.
• Ability to write standard operating procedures and method validation reports.
• Ability to read and interpret technical procedures and governmental regulations.
• Ability to apply mathematical operations to different testing designs.
• Problem-solving and interpersonal skills.
• Core Competencies: Put the Customer First - Think and act with a customer-centric mindset to deliver exceptional customer experiences. Own Your Results - Take personal accountability for all you do and always exercise good judgment. Find a Better Way Every Day - Be intellectually curious and embrace Practical Process Improvement (PPI).
• Mathematical Skills, Time Management Skills, Organizational Skills.