QC Scientist II - Micro Lab

QC Scientist II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

GROUP/DIVISION SUMMARY

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

POSITION SUMMARY

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 solution.

Key Responsibilities:

• 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.

Qualifications:

• 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 judgement. Find a Better Way Everyday - Be intellectually curious and embrace Practical Process Improvement (PPI).
• Mathematical Skills, Time Management Skills, Organizational Skills