QA/QC Technician
Company Overview:
Novel Biome is a pioneering biotechnology company at the forefront of microbiome research and development. We specialize in the manufacturing of Fecal Microbiota Transplant (FMT) drug products that are used in the treatment of C.diff and other approved medical conditions. Our mission is to leverage the potential of the human microbiome to revolutionize healthcare and improve patients lives.
Position Overview:
As a QA/QC Technician at Novel Biome, you will play a crucial role in ensuring the quality and integrity of our products and processes. Working closely with the Quality Assurance and Quality Control manager, you will be responsible for conducting various tasks to maintain compliance with regulatory standards and internal quality requirements. This role requires meticulous attention to detail, strong analytical skills, and a commitment to upholding the highest standards of quality in all aspects of our operations.
Type: Full-Time On-site
Key Responsibilities:
- Monitor manufacturing and laboratory processes to ensure compliance with Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and regulatory requirements.
- Perform routine quality testing and inspections on raw materials, in-process samples, and finished products using analytical instruments and equipment.
- Record and analyze test results accurately, maintaining detailed records of all quality control activities.
- Participate in internal audits and inspections to identify areas for improvement and ensure corrective actions are implemented in a timely manner.
- Pepare and maintain documentation related to quality control activities, including test reports, inspection records, and deviation reports.
- Generate quality metrics and reports to track key performance indicators (KPIs) and trends, providing insights for continuous improvement efforts.
- Perform line clearance, inspections, and physical testing in manufacturing areas
- Interpret generated data and communicate results to Quality management
- Perform calibration and maintenance of laboratory equipment and instruments according to established schedules and procedures.
- Ensure equipment is operating within specified parameters and troubleshoot any issues as needed.
- Maintain effective communication and partnership with the Operations and Production department
- Other duties, responsibilities and qualifications may be required and/or assigned as necessary
Qualifications:
- 3-5 years of experience as a QC technician
- At a minimum, a 2-year certificate in a scientific discipline from an accredited college (preferred: a science degree).
- QA experience in a manufacturing environment preferred
- Previous GMP experience preferred; GMP training provided by Novel Biome
- Strong attention to detail and accuracy in recording and documenting quality control data.
- Dedication to production quality
- Experience with production planning
- Familiar with equipment calibration techniques
- Excellent computer skills in a Microsoft Windows environment. Must include Excel and skills in database management and record-keeping
- Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced environment.
- Proficiency in performing analytical tests and interpreting test results using laboratory instrumentation and equipment.
- Familiarity with quality management systems, GMP regulations, and laboratory practices.
- Excellent communication and teamwork skills, with the ability to collaborate effectively with cross-functional teams.
Benefits:
- Competitive salary and extended healthcare
- Opportunity to work with a dynamic and innovative team.
- Contribute to groundbreaking advancements in biotechnology and healthcare.
- Professional growth and development in a cutting-edge industry.
Note: Only candidates selected for an interview will be contacted. We appreciate your understanding.