"Alerted.org

Work Schedule

First Shift (Days)

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

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

Provides routine analyses in a microbiology environment by following standard practices. Performs analytical methods as assigned for testing on raw materials, samples, stability, environmental and production intermediates. Supports internal development and/or manufacturing operations. Makes detailed observations, documents and communicates test results per cGMP. **Typical hours are 8:00am - 4:30pm, including rotating weekend work.**

Key Responsibilities:

+ Perform a variety of microbiological and bioanalytical testing; including Sterility Testing Bacterial, Endotoxin Testing, Particulate Matter, membrane filtration, TOC and conductivity to support release of product and making quality decisions.

+ Generate valid data, document testing procedures and results in appropriate notebooks and database according to cGMP

+ Compare laboratory results with specifications for acceptability and determines with QA and Management if repetition or OOS is required.

+ Maintain equipment and laboratory cleanliness and report any issues to supervisor. Conducts tasks in a safe manner.

+ Follow scheduled assigned activities to meet target dates for customer needs.

+ Interact effectively with teams across departments and functions to increase efficiency, solve problems, generate cost savings and improve quality.

+ Perform all duties in strict compliance with Safety guidelines and procedures, Standard Operating Procedures, Good Manufacturing Practices and Good Laboratory Practices. Maintains the necessary compliance status required by company.

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.

+ 0-2 years related experience in a Pharmaceutical Microbiology laboratory or related experience.

+ Good knowledge and understanding of chemistry and analytical instrumental technologies.

+ Highly organized, diligent 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

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!

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.