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Quality Assurance Laboratory Technician
2 months ago
About DivIHN Integration Inc:
DivIHN Integration Inc. is a CMMI ML3-certified provider of Technology and Talent solutions. We pride ourselves on fostering meaningful connections between skilled professionals and innovative organizations. Since our inception in 2002, we have been a trusted partner for both commercial and public sector entities in building exceptional teams with temporary and permanent talent.
Position: Quality Assurance Laboratory Technician
Location: Marion, NC
Duration: 6 months
Role Overview:
As a Quality Assurance Laboratory Technician, you will play a crucial role in ensuring the integrity of our environmental monitoring program. Your responsibilities will include:
- Conducting various tests such as water quality assessments, surface sampling, viable air monitoring, and total particle counts in the air.
- Performing routine risk evaluations and HEPA filter inspections within controlled environments.
Your Team:
Every member of our Quality team contributes significantly to our mission. The products we manufacture are distributed globally to patients in need. In this environment, you will have the opportunity to innovate and address challenges directly, with a focus on quality over quantity.
Key Responsibilities:
- Collecting environmental monitoring samples throughout the facility according to established Standard Operating Procedures.
- Gathering water samples on a defined schedule and processing them for microbial testing.
- Conducting weekly Real Time Risk Assessments (RTRA) to identify potential contamination risks.
- Reviewing Environmental Events/Deviations to ensure thorough documentation and testing prior to approval.
- Collaborating with Quality Operations, Manufacturing, and Engineering teams to initiate corrective actions when necessary.
- Leading investigations into microbial out-of-limit occurrences, determining root causes, and implementing effective corrective actions.
- Maintaining clear communication with all staff levels regarding investigation statuses.
- Ensuring a clean and safe work environment by applying 6S principles.
Qualifications:
- B.S. degree in Microbiology, Biology, or a related field.
- 0-2 years of relevant experience, preferably in the Pharmaceutical or Medical Device industry.
- Experience in conducting root cause investigations in the pharmaceutical/medical products sector is preferred.
- Strong communication and project management abilities.
- Proficient in Microsoft Office applications.
- Ability to work effectively in a team-oriented environment.
- Attention to detail and strong organizational skills.
- Familiarity with laboratory instrumentation and Good Documentation Practices (GDPs).
Additional Information:
This job description is intended to provide a general overview of the position and is not exhaustive. Responsibilities may evolve over time, and the successful candidate may be required to comply with health and safety regulations.
