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Quality Assurance Laboratory Technician

2 months ago

Marion, North Carolina, United States DivIHN Integration Inc Full time
Job Overview

For inquiries regarding this opportunity, please reach out to our Talent Specialists.

Position: Quality Assurance Laboratory TechnicianLocation: Marion, NCDuration: 6 monthsThis role involves water sampling and investigative support, operating during standard business hours from Monday to Friday, 8 AM to 5 PM, and requires 100% onsite presence.Role Responsibilities
  • Facilitates the environmental monitoring program by executing tests such as water analysis, surface evaluations, viable air assessments, and total particle counts in the air.
  • Conducts routine risk evaluations and HEPA filter assessments within controlled environments.
Team Dynamics
  • Every position within Quality plays a crucial role.
  • The products manufactured are distributed globally to meet patient needs.
  • Team members are empowered to innovate solutions for new processes or production challenges.
  • Regardless of your specific role, your contributions will impact our worldwide operations.
  • Our mission is to save and sustain lives, which is reflected in all our actions.
  • When faced with choices between quantity and quality, we prioritize quality.
  • Our patients are our top priority, always.

Key Responsibilities
  • Collect environmental monitoring samples throughout the facility according to established procedures on a scheduled basis.
  • Gather water samples on a daily, weekly, or monthly schedule.
  • Process water samples for testing microbial total counts and coliform presence.
  • Capable of climbing ladders or scaffolding for water sampling tasks.
  • Conduct weekly Real-Time Risk Assessments (RTRA) to identify potential contamination risks in controlled environments.
  • Review Environmental Events/Deviations to ensure complete documentation and testing before submission for approval.
  • Build collaborative relationships with Quality Operations, Manufacturing, and Engineering to initiate corrective actions when issues arise.
  • Lead investigations into microbial out-of-limit occurrences, determining root causes and defining effective corrective or preventive measures.
  • Collaborate with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure timely and accurate determination of scope, product impact, root cause, and CAPAs.
  • Engage with all levels of staff, providing timely updates on investigation progress.
  • Foster collaborative relationships focused on high-quality investigations, effective corrective actions, and reducing out-of-limit occurrences.
  • Ensure timely closure of investigations to meet business and compliance requirements.
  • Work independently to drive investigations to completion.
  • Manage multiple investigations concurrently.
  • Complete testing within required timeframes.
  • Coordinate validation protocols with Technical Services and Microbiology teams.
  • Maintain a clean and safe work environment by applying 6S principles.
Qualifications
  • Bachelor's degree in Microbiology, Biology, or a related scientific field.
  • 0-2 years of experience; at least 1 year in the Pharmaceutical or Medical Device industry is preferred.
  • Experience in conducting root cause investigations in the pharmaceutical or medical products sector is advantageous.
  • Strong communication and project management skills.
  • Familiarity with core manufacturing and support systems.
  • Proficient in Microsoft Office applications (Word, Excel).
  • Excellent interpersonal skills and ability to work effectively in a team-oriented environment.
  • Proficient in aseptic techniques and handling media plates and swabs for environmental monitoring sampling.
  • Self-motivated individual requiring minimal supervision.
  • Strong attention to detail and organizational skills.
  • Basic understanding of laboratory instrumentation.
  • Good documentation skills and knowledge of Good Documentation Practices (GDPs).
  • Able to manage multiple tasks and priorities efficiently.
  • Knowledge of aseptic techniques and microbiological testing according to FDA, cGMP, GLPs, and USP methodologies.
  • Familiarity with LIMS (or equivalent systems) and TrackWise is a plus.
  • Able to communicate effectively with supervisors and peers.
  • Knowledge of FDA quality system regulations is preferred.
Additional Information
  • This job description is not exhaustive and may be subject to change.
  • Overtime may be required as necessary.
  • The successful candidate may need to verify vaccination against COVID-19, with reasonable accommodations for medical or religious exemptions.
  • We seek candidates with GMP or laboratory experience, knowledge of aseptic techniques, and investigation experience is a plus but not mandatory.
  • Ideal candidates may be recent graduates with relevant internship or academic experience.
  • Good communication skills and basic proficiency in MS Office are essential.
  • Ability to lift up to 25 pounds is required.
  • Experience with tools or technology is not mandatory but familiarity with LIMS and MS Office is advantageous.
  • The interview process will include a Teams call with the team and manager.
  • Preferred educational background includes science, microbiology, biology, chemistry, environmental science, or biochemistry.


About DivIHN:DivIHN Integration Inc specializes in IT Asset Performance Services, offering Professional Consulting, Custom Projects, and Resource Augmentation services to clients across the Mid-West and beyond. Our strategic focus emphasizes Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer, committed to diversity and inclusion in the workplace.