QC Scientist I (Micro) at Thermo Fisher Scientific in High Point, North Carolina

Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)



Job Description





Location/Division Specific Information:



As part of the Pharma Services Group (PSG), the High Point, NC site focuses on gelatin-based drug delivery dosage forms (softgels). We offer extensive development and commercial scale capabilities for a variety of softgels technologies.




How Will You Make an Impact



Are you a skilled and motivated Quality Control Scientist I? Join our exceptional team within the Quality organization at our facility and seize this exciting opportunity to make a significant impact.You will play a crucial role in supporting our workstream teams to meet the rapidly expanding needs of our clients. Get ready to contribute your expertise and be part of our journey to deliver unparalleled service and satisfaction to our valued clients. This is your chance to thrive and excel in a dynamic and exciting environment!


Summary:


Provides routine analyses in a microbiology laboratory by following standard practices. Performs microbiological methods as assigned for testing on raw materials, finished products, stability, and environmental samples. Supports internal development and/or manufacturing operations. Makes detailed observations, documents, and communicates test results.


Functions:


1. Conducts routine microbiological testing of finished products, raw materials, and stability samples by internally developed and compendial test methods.


2. Environmental Monitoring testing


3. Purified Water testing


4. Complete other testing/cleaning in the department


5. Conduct inspections of samples to ensure they meet predetermined quality standards and specifications.


6. Gaining proficiency in sample preparations and testing using various equipment throughout QC in various areas


7. Perform functional testing of products according to established protocols and procedures.


8. Identify and document any atypical, out of specification or results.


9. Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems.


10. Performs daily instrument calibrations / verifications


11. 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.


12. Cleans and organizes work area, instrumentation, and testing materials.


13. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains compliance status required by company and facility standards.


Documentation and Reporting:


• Maintain accurate and detailed records of inspections.


• Record non-conformances, corrective actions, and preventive measures.


Compliance and Standards:


• Ensure all quality control activities align with ISO 13485 and other relevant regulatory standards.


• Assist in internal and external audits, providing documentation and support.


• Work closely with the Quality Control team to address and resolve quality issues.


• Communicate efficiently with other departments to ensure standards are understood and met.


• Provide guidance to production staff on quality and standards as needed.


Continuous Improvement:


• Participate in continuous improvement initiatives to enhance product quality and production efficiency.


• Find opportunities for process improvements and supply to the development and implementation of quality processes.


Education:


Bachelor's degree in physical science, preferably in Chemistry, Biology, or Microbiology.


Experience:


• Knowledge of QC testing principles and procedures, as applicable to focus of position.


• Extensive exposure to cGMP environment.


• Significant laboratory documentation practices and ALCOA Principals.


• Shown understanding of quality control principles, regulatory requirements, and ISO 13485 standards.


• Excellent attention to detail and problem-solving skills.


• Effective and collaborative communication.


• Independent and group work.


Work Environment:


• The job is performed in the Microbiology Laboratory and the production floor, which may involve exposure to bacteria, odors, noise, dust, and varying temperatures.


• Personal protective equipment (PPE) may be required.


Equivalency:


Equivalent combinations of education, training, and meaningful work experience may be considered.


Proficiencies:


Good knowledge and understanding of basic instrumental technologies. Knowledge of qualitative and quantitative chemical or microbiological analysis. Awareness of quality and regulatory requirements in the pharmaceutical industry. Good problem-solving skills and logical approach to solving scientific problems. Confirmed interpersonal and communication (both oral and written). Ability to read and interpret technical procedures and governmental regulations. Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques.


Knowledge, Skills, Abilities


•Team focus.


•Written, verbal, and the ability to work independently.


• Individual should be able to working in a cGMP clean room environment for extended periods of time


-Fast-paced environment.


• Experience (2+ years) in MS Excel, Word, and Outlook


• Communication is required to be effective in this role.


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, latex or similar gloves, safety apron, organic respirator occasionally.



Excellent Benefits!

• Benefits & Total Rewards | Thermo Fisher Scientific


• Medical, Dental, & Vision benefits-effective Day 1


• Paid Time Off & Designated Paid Holidays


• Retirement Savings Plan


• Tuition Reimbursement


• Employee Referral Bonus


• Career Advancement Opportunities