QC Scientist II (Environmental Monitoring - 12 Hour Days)
Thermo Fisher Scientific

Job Description

COMPANY INFORMATION

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

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

A successful person will perform Environmental Monitoring tasks in support of Steriles production within classified areas. The individual is encouraged to follow the 4i Values that are held in high regards by the company when completing their work. The four values are integrity, innovation, intensity, and involvement. The job function includes aseptic technique which requires the individual to gain knowledge of aseptic gowning as well as working in cleanrooms in order to monitor the area while sterile products are filled and manufactured. Typical shift hours are 6p-6a on a 2-2-3 rotating schedule.

Key Responsibilities:

• Verifies and processes environmental monitoring data.
  

• Carries out moderately sophisticated validated test methods for routine, special projects and batch related environmental monitoring in clean rooms (i.e. classified areas and aseptic processing).
  
• Decides appropriate testing methods will be used.
  
• Reports or makes determination out-of-specification or unexpected results, due to environmental impacts or other to reach resolution.
  
• Reading and verification of media plates.
  
• Maintains and troubleshoots instrumentation as needed.
  
• Accurately records, reports and communicates results of analysis in accordance with prescribed lab procedures and systems.
  
• Leads, prepares, and files regulatory documents in support of internal projects.
  
• Provides communications with outside departments, corporate sites, agencies, and clients.
  
• Coordinates, assists and leads in the writing of SOPs, policy manuals, and other instructional documents.
  
• Responsible for care and cleanliness of equipment, and testing materials.
  
• Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, ALCOA, Audits and Safety guidelines.
  
• Maintains the necessary training, compliance status required by company and facility standards.
  
• Other duties as assigned.
  

Qualifications:

• Bachelor's degree in a biology/ related field is preferred. An associate's degree in a science related field, preferably Biology, is minimally required.
  
• 3+ years related experience performing chemical tests with chromatographic, spectroscopic, or other analytical techniques, working knowledge of EMPOWER is a plus. Including experience in performing aseptic techniques, clean room activities or related experience.
  
• Perform analyses including instrumental and automated methods using prescribed procedures and techniques.
  
• Generate valid data, report results on appropriate database compared to established specifications while adhering to GMPs.
  
• Maintain equipment and troubleshoot instrumentation problems, procedural problems or production problems.
  
• Schedule activities to meet target dates for customer needs.
  
• Follow all job-related safety and other training requirements.
  
• Performs tasks as assigned by area supervision or designee.
  
• Able to withstand extended periods of standing and/or walking and bending.
  
• Interpersonal communication (Oral and Written- Legible handwriting)
  
• Presentation and Time Management
  
• Proven understanding of qualitative and quantitative microbiological analysis. Knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs.
  
• Presentation skills to deliver information to customers, clients, and other employees.
  
• Ability to read, analyze, and interpret technical procedures and governmental regulations.
  
• Ability to respond to common inquiries or complaints from customers or regulatory agencies.
  
• Ability to mentor and train junior team members.
  

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 extended time frames. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials. 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!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/disability access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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