Executive and Administrative Assistant ID-20196
Overview
The QA and Regulatory Compliance Specialist will assist the Quality and Regulatory department
at The BioBox, LLC. The Specialist will support all aspects of QA and Regulatory Compliance,
perform routine QA procedures, review, and verify QC operations and records, and ensure
compliance with applicable regulations. The ideal candidate will have experience with quality
systems and documentation, cleanroom environmental and personnel monitoring, aseptic and
GMP production, laboratory EH&S, FDA regulations, and basic knowledge of cell culture and
procedures used with human cells and cell-based products. In addition, the ideal candidate
should have good knowledge of general biology and the translational aspect of drug discovery
as it applies to taking cell-based technologies from research into development of clinically
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therapeutic products. The successful candidate should have an interest and aptitude for communicating, collaborating with scientists, and promoting awareness and adherence to regulations, quality standards, and GMP. This position requires meticulous attention to detail, proficient technical writing, and the ability to understand lab procedures sufficiently to draft and review SOPs, material specifications, and other QA documents and reports. This position should be capable of supporting product realization, helping to maintain the corporate quality management system for compliance with applicable regulations.
Responsibilities
- Review lab forms, logs, batch records, and QA/QC records. Maintain QA binders.
- Maintain vendor/supplier qualification, review material specifications, and effect proper QA release of materials received for in-house lab and production use.
- Identify, draft, review, revise SOPs, forms, batch records, and other documents as needed to maintain adherence with applicable regulations.
- Implement/monitor/enforce lab policies, process improvements, completion of all temperature readings and data entries on all laboratory forms and logs, GDP, and employee safety.
- Maintain, review and filing of all lab, equipment, and cleanroom daily/weekly/monthly logs and forms in appropriate QA binders.
- Maintain and manage environmental monitoring and personnel monitoring programs; including training, ordering of all plates, transferring of all plates, shipment of all plates to USMS as needed, reporting, data entry and dispositions of all reports and corresponding forms.
- Assist in implementing appropriate corrective and preventive actions.
- Participate in audits, deviation reports, and investigating/documenting CAPAs as assigned.
- Collaborate with scientists and production staff to continually improve compliance and documentation to ensure quality and efficiency.
- Assist with drafting data capture tools and drafting reports in support of regulatory submissions.
Note: This is NOT an all-inclusive list of responsibilities. It is expected that each jobholder can react to reasonable change productively and handle other essential tasks assigned. All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role.
Experience
- Bachelor’s/Master’s in basic science (cell biology, molecular biology, biochemistry, clinical laboratory science), preferred.
- 2+ years of experience in regulatory compliance in academia or industry.
- 2+ years of experience in QA, QC, or the development and implementation of a Quality System.
- Understand requirements for cGMP, GTP, and GDP compliance.
- Demonstrate attention to detail in documentation, as well as in oral and written communications.
- Experience with laboratory management, including employee and environmental health and safety, clean room requirements, and laboratory equipment maintenance.
- Technical trouble-shooting and problem-solving skills are a plus.
- Working knowledge of standard scientific, analytical, and statistical principles.
- High standards of organization, meticulous attention to detail, time management, integrity, and work ethic.
- Ability to work under supervision, follow priorities, and provide leadership in a team environment; as well as ability to take direction and work independently on routine tasks.
- Commitment to quality, accuracy, efficiency, and communication.
- Self-motivated and willing to learn and grow with a small company.
- Proficient in Microsoft Office Suite and Adobe Acrobat Pro.
Job Type: Full-time
Pay: $68,640.00 per year
Benefits:
- 401(k)
- Dental insurance
- Employee assistance program
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: In person
Job Type: Full-time
Pay: $20.00 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- Dental insurance
- Employee assistance program
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Work Location: In person
