Quality Control Specialist

**Key Responsibilities**:

- **Quality Control Testing**: Conduct rigorous quality control testing on raw materials, intermediate products, and finished goods to ensure compliance with industry standards and specifications.
- **Documentation and Recordkeeping**: Maintain accurate records of all quality control tests, inspections, and activities. Ensure all documents are properly filed, organized, and compliant with regulatory requirements (e.g., GMP, GLP).
- **Compliance and Standards**: Ensure that all products and processes comply with regulatory standards (FDA, EMA, etc.), industry best practices, and company-specific procedures.
- **Inspection and Monitoring**: Inspect production batches and oversee monitoring of manufacturing processes to ensure that all steps follow the required quality standards.
- **Deviation Management**: Investigate deviations from standard procedures and implement corrective actions as necessary. Analyze trends and recurring issues to identify root causes and prevent future occurrences.
- **Process Improvement**: Collaborate with other departments to continuously improve quality control processes, implement efficiency improvements, and minimize risks associated with quality defects.
- **Training**: Provide training to new staff and production teams on quality control standards, procedures, and regulatory requirements.
- **Equipment Calibration and Maintenance**: Ensure that laboratory and production equipment is properly calibrated, maintained, and in good working condition. Organize regular inspections and troubleshooting as needed.
- **Product Testing and Validation**: Perform analytical testing using appropriate laboratory techniques (e.g., chromatography, PCR, ELISA) and validate test results to support the release of products.
- **Reporting**: Prepare and present quality control reports to management, highlighting key quality metrics, product testing results, and any areas requiring attention.
- **Supplier Quality Control**: Review and evaluate supplier quality to ensure materials and components meet specifications before they are used in production.

**Qualifications**:

- Bachelor’s degree in Biotechnology, Biology, Chemistry, or a related field (or equivalent work experience).
- Proven experience in quality control, quality assurance, or a similar role within the biotechnology or pharmaceutical industry.
- In-depth knowledge of quality control methods, techniques, and regulatory requirements (GMP, GLP, ISO standards).
- Strong understanding of laboratory equipment, testing procedures, and data analysis.
- Experience with microbiological testing, analytical chemistry, or molecular biology methods is a plus.
- Ability to analyze complex data and identify trends, deviations, and potential areas of improvement.
- Excellent organizational and recordkeeping skills, with a strong attention to detail.
- Strong communication skills, both written and verbal.
- Ability to work independently and as part of a collaborative team.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with laboratory management software is a plus.

**Work Environment**:

- Full-time position.
- Laboratory-based role, with potential for some office work.
- Opportunity for professional development and growth within the company.

**Why Join Us?**
Areca Bio is committed to advancing biotechnological solutions that improve the quality of life. As a **Quality Control Specialist**, you will play a crucial role in ensuring that our products are safe, effective, and of the highest quality. You will be part of an innovative and growing company, working alongside passionate professionals dedicated to making a positive impact in the biotechnology and healthcare fields. We offer competitive compensation, benefits, and opportunities for career growth in a dynamic and supportive work environment.

Pay: $81,865.00-$84,637.00 per year

Additional pay:

- Bonus pay

Schedule:

- Monday to Friday

Work Location: In person