QC Scientist II - Microbiology

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

The QC Scientist II Provides moderately sophisticated analyses in a microbiology lab environment within defined procedures and practices. Performs analytical methods for moderately sophisticated 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.
• Performs 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:

• Bachelors 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, thorough 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
• Strengths You'll Need: 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 Every day - Be intellectually curious and embrace Practical Process Improvement (PPI).

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.

What We Offer

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!

Compensation

• Competitive Hourly Pay Rate
• Additional shift differential for 2nd shift and 3rd shift positions
• Annual performance-based bonus
• Annual merit performance-based increase

Excellent Benefits

• Benefits & Total Rewards | Thermo Fisher Scientific
• Medical, Dental, & Vision benefits-effective Day 1
• Paid Time Off & Designated Paid Holidays
• 401K
• Tuition Reimbursement
• Employee Referral Bonus
• Career Advancement Opportunities

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 at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!

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.

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