What are the responsibilities and job description for the Quality Control Specialist position at Valogic Bio Llc?
About VaLogic Bio, LLC
VaLogic Bio provides crucial technology and compliance services to clients in the life sciences and biotechnology industries; helping organizations establish and remain FDA compliant.
Our client services allow scientists to focus their time on the advancement of their life-enhancing therapeutics. This is done through a suite of services that include advisory and facility design, equipment calibration and validation, commissioning, preventative maintenance, laboratory and cleanroom environmental monitoring, and SaaS technology for compliance and continuous monitoring.
Job Title: Quality Control Specialist
Position Summary: The Quality Control (QC) Specialist is responsible for routine and non-routine sampling and testing for environmental monitoring, clean utilities, gas, TOC, conductivity and Bioburden Testing.
Duties and Responsibilities:
- Perform routine Environmental Monitoring, clean utility/gas sampling, TOC, Conductivity, and Bioburden testing. Will require routine travel to client site to collect routine samples for testing
- Perform analytical testing, interpret results, and document actions and results using proper documentation practices
- Perform required data analysis, compile data and prepare results for review
- Conduct enumeration of viable air samples, microbial identification, bioburden analysis, and sterility testing
- Conduct routine tests (Microbial colony count, bioburden testing, coliforms, TOC, conductivity, etc.) using appropriate tools and equipment to verify compliance with specifications
- Performs routine lab cleaning and equipment maintenance activities in accordance with SOPS as scheduled, and escalates potential equipment issues to supervisor
- Review of laboratory notebooks, protocols and reports
- Responsible for data documentation and technical writing, inclusive of laboratory investigations and deviations
- Leading the lab in 5S and routine housekeeping activities
- Implement new equipment following analytical instrument qualification guidance.
- Assist with the administration of electronic data system
- Other duties as assigned
Qualifications and Skills:
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Education and Experience
- BS in Microbiology or related field
- 3 years experience working in GMP laboratory, preferably related to biopharmaceutical industry operations.
- Comprehensive GMP Environmental Monitoring experience required
- Skills and Abilities
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Technical Skills:
- Proficiency in using quality inspection tools and software.
- Knowledge of quality standards (e.g., ISO 9001, Six Sigma, etc.).
- Hands on experience performing, bioburden, coliform, TOC, Conductivity testing
- Excellent analytical skills and knowledge
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Soft Skills:
- Strong attention to detail and analytical skills
- Excellent communication and teamwork abilities
- Problem-solving mindset with the ability to make data-driven decisions
Work Environment:
- This role may involve working in manufacturing, laboratory, or office settings.
- Some positions may require standing for extended periods or working in environments with noise or temperature fluctuations.
- Position requires up to 40% travel to clients site and occasional weekend work
Benefits
We currently offer a robust suite of employee benefits including:
Medical & Prescription Coverage Supplemental Life and AD&D
Dental Coverage Short- and Long-Term Disability
Vision Coverage Employee Assistance Program
Health Savings Account (HSA) Unlimited Paid Time Off
Basic Life and AD&D 11 Paid Company Holidays
EEO Statement
VaLogic Bio, LLC is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
VaLogic Bio, LLC (VaLogic) does not accept unsolicited resumes from search firms or any other third parties. Any unsolicited resume sent to VaLogic will be considered VaLogic property, and VaLogic will not pay a fee should it hire the subject of any unsolicited resume.
