Quality Assurance Specialist
2 weeks ago
Position Title: Quality Assurance Specialist
Location: Norwood, MA
Duration: 6 Months
Role Overview:
The Quality Assurance Specialist will focus on conducting rigorous testing in the realms of molecular biology and cell culture. A minimum of 3 years of experience in a GMP environment is essential.
Key Responsibilities:
- Conduct QC molecular biology and bioassay methodologies, including qPCR, sequencing, and protein expression.
- Provide troubleshooting support for equipment and assay-related challenges.
- Engage in laboratory support tasks such as reagent preparation, equipment upkeep, and maintaining laboratory cleanliness.
- Ensure a safe and compliant laboratory environment.
- Draft, update, and uphold standard operating procedures (SOPs), protocols, and documentation.
- Facilitate training sessions as required.
- Assist in managing quality records, including investigations and change controls.
- Adhere to all relevant GxP regulations and company policies to maintain compliance with internal and regulatory standards.
- Execute tasks in accordance with established internal guidelines, including SOPs and work instructions.
- Maintain Good Documentation Practices and Data Integrity standards to ensure accurate data and documentation.
- Complete required training in a timely manner and adhere to requalification schedules.
- Additional responsibilities may be assigned as necessary.
Qualifications:
Basic Requirements:
- Education: BA/BS Degree in a relevant field.
- Experience: 3-5 years in a cGMP laboratory setting, with hands-on experience in molecular biology and cell-based assays.
- Certifications: None required.
Preferred Qualifications:
- Experience in method development and qualification for molecular biology and protein analysis.
- Proficiency in aseptic techniques and laboratory instrumentation.
- Ability to prepare reagents and work within a Biological Safety Cabinet.
- Experience with calibration and maintenance of laboratory equipment.
- Capacity to thrive in a dynamic, cross-functional environment.
- Familiarity with FDA, EU, and ICH guidelines and regulations.
- A commitment to contributing positively to a high-growth, transformative organization.
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