Quality Control Laboratory Technician
1 week ago
Position: Quality Control Laboratory Technician
Location: Marion, NC
Contract Duration: 6 months
Role SummaryAs a pivotal member of our team, you will leverage your analytical skills to tackle various challenges in our quality assurance processes.
Key Responsibilities- Assist in the environmental monitoring initiative by executing tests including water analysis, surface evaluations, viable air assessments, and total particulate air counts.
- Conduct regular risk evaluations and HEPA filter inspections within controlled environments.
In our Quality department, every position contributes significantly to our mission. Our products are distributed globally to support patients in need. Team members are empowered to innovate solutions, whether developing new processes or overcoming unforeseen production challenges. Quality is our priority, and we always place patient safety at the forefront of our operations.
Responsibilities Include- Gather environmental monitoring samples throughout the facility according to established protocols on a scheduled basis.
- Collect water samples routinely for analysis.
- Process water samples to test for Microbial Total Count and Coliform.
- Utilize ladders or scaffolding as necessary for sample collection.
- Conduct weekly Real Time Risk Assessments (RTRA) to identify potential contamination risks in controlled areas.
- Review Environmental Events/Deviations to ensure all documentation and testing are complete before seeking approval.
- Collaborate 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 implementing effective corrective actions.
- Work closely with Quality, Operations, Engineering, Maintenance, and Supply Chain to ensure timely resolution of issues.
- Communicate with all staff levels, providing updates on investigation progress.
- Foster collaborative relationships to ensure high-quality investigations and effective corrective measures.
- Complete investigations promptly to meet business and compliance requirements.
- Manage multiple investigations simultaneously.
- Ensure testing is completed within designated timeframes.
- Coordinate Validation Protocols with Technical Services and Microbiology teams.
- Maintain a clean and safe work environment by applying 6S principles.
- Bachelor's degree in Microbiology, Biology, or a related field.
- 0-2 years of relevant experience; at least 1 year in the Pharmaceutical or Medical Device sector preferred.
- Experience in conducting root cause analyses in the pharmaceutical or medical products industry is advantageous.
- Strong communication and project management capabilities.
- 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.
- Skilled in aseptic techniques and handling media plates and swabs for environmental monitoring.
- Detail-oriented with strong organizational abilities.
- Basic understanding of laboratory instrumentation.
- Good documentation practices and knowledge of GDPs.
- Able to manage multiple tasks and priorities efficiently.
- Knowledge of aseptic techniques and microbiological testing in accordance with FDA, cGMP, GLPs, and USP methodologies.
- Familiarity with LIMS or similar systems.
- Effective communication skills with supervisors and peers.
- Understanding of FDA quality system regulations is preferred.
This job description is intended to outline the primary duties and responsibilities of the position. Duties may evolve over time, and the successful candidate may be required to verify vaccination status against COVID-19, subject to reasonable accommodations for medical or religious reasons.
About DivIHNDivIHN, the 'IT Asset Performance Services' organization, specializes in Professional Consulting, Custom Projects, and Resource Augmentation services across the Mid-West and beyond. Our strategic focus is on Standardization, Specialization, and Collaboration.
DivIHN is an equal opportunity employer and does not discriminate against any employee or qualified applicant based on race, color, religion, gender, age, national origin, disability, marital status, sexual orientation, or military status.
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