Position: QC/QA Manager and Scientist
Location: South Austin, TX (On-site)
Company: Biotechnology Company
We are looking for a skilled and experienced QC/QA Manager and Scientist to lead our quality control and quality assurance efforts while also participating in hands-on scientific research. This dual role requires expertise in laboratory practices, regulatory compliance, and scientific research methods. The QC/QA Manager and Scientist will ensure that our lab adheres to the highest regulatory standards while actively contributing to the scientific research process.
Responsibilities:
Quality Control/Quality Assurance Management:
Develop, implement, and maintain QC/QA procedures to ensure regulatory compliance (GMP, GLP, and other relevant standards)
Conduct internal audits, inspections, and ensure continuous adherence to quality standards
Monitor the calibration, validation, and maintenance of laboratory equipment to comply with federal and QA/QC regulations
Troubleshoot and resolve technical problems related to QC/QA practices and lab processes
Create, update, and enforce SOPs (Standard Operating Procedures), laboratory safety guidelines, and regulatory documentation
Collaborate with management to establish QA/QC policies and drive continuous improvement initiatives
Scientific Research:
Design and conduct laboratory experiments and perform both routine and advanced assays
Develop and investigate new procedures, research protocols, and assays in compliance with regulatory standards
Provide technical advice to lab staff on research methods and ensure alignment with QC/QA standards
Ensure accurate reporting of data and results, and maintain detailed research documentation using SEND software and other data management tools
Stay current on scientific advancements and regulatory updates relevant to the research and biotech industries
Qualifications:
BS, MS, or PhD in Biotechnology, Molecular Biology, Biochemistry, or a related field
Extensive experience in QC/QA roles within biotechnology, pharmaceuticals, or life sciences
Strong understanding of regulatory requirements (GMP, GLP, QA/QC) and hands-on experience in maintaining laboratory compliance
Proven track record of performing scientific research and laboratory work, with proficiency in cell and molecular biology methods
Experience in writing and managing SOPs, laboratory safety guidelines, and other regulatory documentation
Familiarity with SEND software and other laboratory data management systems
Excellent attention to detail, problem-solving, and troubleshooting skills
Ability to lead, train, and collaborate with laboratory teams on both scientific and quality control matters
Compensation:
Salary range: $30-45 per hour ($70,000-$95,000 annual), based on experience
Full-time (40 hours/week) or part-time (20 hours/week) options available starting December 2024
Initial 3-month probationary contract, with the possibility of a permanent position based on performance and project success
Background Checks:
A criminal history background check will be required for finalist(s) under consideration for this position. You will also be required to present acceptable documents to verify identity and employment eligibility in the U.S.
Relocation Assistance:
No relocation assistance available
