Quality Assurance Technician
Genelux Corporation is an oncolytic immunotherapy company headquartered in San Diego, California.
Our vision is to build a pre-eminent immuno-oncology company that addresses serious unmet medical needs.
Our mission is to develop immunotherapeutics that deliver the full complement of tumor neo-antigens with the power to stimulate a personalized immune system response to fight cancer, individual by individual.
Title: Quality Assurance Technician
Employment Type: Full-time, Temporary Assignment
Location: San Diego, CA
Position reports to: Quality Assurance Manager
Subordinated positions (titles): None
In-Person/Work-from-Home: This is an in-person, on-site, role.
PURPOSE OF POSITION
The Quality Assurance Technician is a dynamic and varied role responsible for monitoring the quality of processes and manufactured products to ensure that the quality system is operating according to FDA Pharmaceutical GMP regulations (21 CFR 211).
Supporting manufacturing, the QA Technician will inspect materials, collecting samples aseptically as required, review and verify batch records, and participate in the aseptic manufacturing space as required.
QMS system operation includes maintaining specific subsystems as assigned by the QA Manager such as Document Control, Validation, Supplier Quality, Internal Audits, CAPA, NC, and Deviations. Other duties may include development and implementation of new procedures, standards and specifications as required by the Quality Management System.
- Perform inspection and testing of raw materials, components, and labels to ensure compliance against purchase specifications prior to disposition to production.
- Review & release of controlled documents per directive of the Quality Assurance Manager.
- Supports ongoing improvements and maturity of the Quality Management System via systematic review and annotation of documents.
- Conducts documentation reviews for cGMP records, including Batch Records, Validation Protocols/Reports, Facility Cleaning/Calibration, etc.
- Support internal audits of departments located in the manufacturing plant and report the results.
- Investigate quality issues raised by production employees and report them to the Quality Assurance Manager
- Participates in production cycle and is responsible for overseeing production of Drug Product, ensuring that all documentation is filled out correctly and completely.
- Supports fulfillment of supplier quality program (qualification, audits, etc.) as required.
- Supports the effort to implement best practices within job scope; expected to participate in activities designed to improve Environmental Health and Safety (EH&S), quality and production.
Performs other related duties as required and assigned.
This position has no direct supervisory responsibilities.
- Determines the efficacy of assigned quality subsystem and make appropriate recommendations to correct or improve the system.
- Determines in-process and finished product conformance to specifications.
- Evaluates procedures for clarity and process flow and makes change recommendations.
- Determines if incoming raw materials, components, and labels meet internal specifications.
- Previous experience within a regulated industry required, with pharmaceutical GMP preferred.
- Fluent in Microsoft Office software.
- Effective communication skills, both verbal and written.
- Ability to work, both independently and as part of a team.
- Excellent organizational skills.
- Strong attention to detail.
- Possess strong ability to perform detailed repetitive tasks with precision.
- Proficient in the use of problem-solving tools to analyze, identify root causes and verify effectiveness of corrective actions.
- Must be able to read English at a minimum ABE level of Intermediate Basic
QUALIFICATIONS & EXPERIENCE
- Associate’s or Bachelor’s Degree in related field preferred.
- Minimum 5 years quality related biologics production experience preferred.
- Minimum 5 years of experience working in a pharmaceutical GMP environment preferred.
- 21 CFR 211, ISO 9001:2008, experience, preferred
- Knowledge of Lean Six Sigma manufacturing methods, preferred
- Prior work experience in a manufacturing environment, preferred.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is regularly required to stand; walk, use hands and talk or hear. The employee is frequently required to reach with hands and arms. The employee is frequently required to walk, and occasionally stoop, kneel, crouch, or crawl. The employee must frequently lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.
Typical work hours and shifts, days and overtime expectations:
This position typically works Monday through Friday from 8:00am to 5:00pm. Occasional overtime work may be required as job duties demand.
Travel: Little to no travel is expected for this position.
Classification (Exempt/Non-exempt): Non-Exempt[RD1]