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.), Strong Odors (chemical, lubricants, biological products etc.)
Job Description
First Shift (Days)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Office, Strong Odors (chemical, lubricants, biological products etc.)
Job Description
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 sophisticated 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 sophisticated microbiological testing of in process products and finished products by internally developed and compendial test methods.
- Performs validated test methods for Bioburden, Microbial Examination Testing, Identification of Organisms, and Growth Promotion 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 acquired 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 prioritizes 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 vital 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.
- Experience with LIMS, SLIM, Trackwise, or Documentum a plus. Experience as a reviewer approver or qualified checker preferred.
- Highly organized, meticulous 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 Proficiencies: Put the Customer First - Think and act with a customer-centric approach 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 adopt Practical Process Improvement (PPI).
- Mathematical Skills, Time Management Skills, Interpersonal Skills
Physical Requirements:
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.
BENEFITS
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!