Grow your quality career in cell therapy at Aspen Neuroscience! We are adding a QA Associate (Document Control) to our highly collaborative team. The ideal candidate is detail-oriented and comfortable in a fast-paced startup environment. Reporting to the Director of Quality Assurance, this role will manage GXP documentation and records, while supporting general QA operations as necessary.
Duties and Responsibilities
- Filing, tracking and archival of GXP documentation
- Consults with end users to identify problems in accessing electronic content
- Ensures security of system and integrity of master documents by implementing document and system access rights and revision controls
- Maintains training records and documentation within Learning Management System.
- Processes document requests to be used in-house in a timely manner
- Ensures basic grammatical accuracy and completeness when processing documents.
- Provides guidance and training to staff regarding quality document control processes
- Receives and maintains all GXP documents, including but not limited to standard operating procedures (SOPs), test methods, specifications, incident reports, CAPAs, Product Complaints, computer system validation, and audit files and records
- Provides reports to Upper Management and Project Management regarding document status
- Maintains databases used for tracking GMP documentation
- Support internal and external audits
- Escalate issues that may adversely impact timely release of product
- Identify compliance risks and escalate the issues to appropriate levels of management for resolution
- Assist in making continuous improvements to the quality systems
Education and Experience
- High school diploma and/or bachelor’s degree and 1-2 years of experience with Good Manufacturing Practices (GMPs) in the pharmaceutical, biologic, or medical device industries in a Document Control position, including the revision, issuance and tracking of batch records, Standard Operating Procedures (SOP), Specifications, etc.
- Experience working in a regulated environment (GMP, GLP) is preferred. Knowledge of regulatory guidelines and requirements (USP/EP compendia, FDA, ISO, GMP, and ICH) applicable to biologics. Experience applicable to cell therapies is a plus
- Exposure to 21 CFR Parts 210 & 211, biotechnology, and electronic validated computer systems a plus
- Proficiency with Microsoft Office applications
The standard work week for this position is M-F; however, occasional weekend work may be required during manufacturing campaigns to support process operations
- Comfortable in a fast-paced, startup company environment, and able to adjust workload based on changing priorities
- Demonstrated ability to work independently with minimal instructions
- Must be detail oriented with strong organizational and documentation skills
- Good oral and written communication skills
EEO and Employment Eligibility
Aspen Neuroscience is committed to providing equal employment opportunities to all employees and job applicants and prohibits discrimination and harassment of any type. We are committed to creating an inclusive environment for all employees.
Total Rewards and Culture
Aspen Neuroscience, Inc., located in scenic Torrey Pines, is noted for its collaborative and learning focused culture where each person is valued for contributing their strengths and energy to building a world-class line of products for patients in need. The company offers a competitive total compensation package, time-off in addition to Company observed holidays, Medical/Dental insurance benefits, gym membership, and other wellness perks.
For immediate consideration, apply here: https://app.trinethire.com/companies/21059-aspen-neuroscience/jobs/58132-quality-assurance-associate-document-control