Our Manufacturing team is growing, and we are looking for a dynamic, detail oriented Manufacturing Technician to join our team. This key role will follow approved procedures and protocols to support the duties of the manufacturing associates and cleaners while reviewing and retaining accurate daily logs and records according to cGMP and cGDP guidelines.
DUTIES AND RESPONSIBILITIES:
- Performs production related tasks that can include, Quality Event Notifications, Facilities Maintenance Requests, ordering of supplies, materials, and equipment for production.
- Set-up and clean-up of MFG suites and staging area.
- Performs materials management activities in accordance with cGMP.
- Wiping and staging material into MFG cleanroom.
- Autoclaving material and equipment.
- Report conflicts immediately to area management or senior associates.
- Reports observed process issues, abnormalities, and deviations immediately to area management and/ or senior associates.
- Collaborates with other departments, such as Quality, on resolutions and improvements for areas such as process flow and biopsy kits.
- May perform light aseptic processing including media formations, coating of plates, and dispensing reagents.
- Assists associates and management during compliance inspections and audit readiness.
- Perform light aseptic processing including media formations, coating of plates, and dispensing reagents.
- Continues personal development and training and ensures any required qualifications are up to date.
EDUCATION AND EXPERIENCE:
- Previous experience with quality systems and/or working in a regulated environment preferred.
- A minimum of <1 year of experience within the pharmaceutical or biotechnology industry.
- HS Diploma or equivalent education required. Associate degree or some science college course work preferred.
JOB SPECIFICATIONS:
- Good understanding of CMC development and manufacturing.
- Strong oral and written communication, interpersonal, analytical and computer skills.
- Attention to detail and effective organizational skills.
- Solid knowledge of Microsoft Office programs and other project management tools.
- Has an eye for safety and risk assessment and knows when to alert management of unsafe practices and/or situations.
- Must be able to stringently follow company rules, regulations, and safety precautions, to maintain quality standards.
- Ability to read and understand SOPs and work instructions and document daily work in a written format applying cGMP standards.
- Ability to meet high department standards of work quality and teamwork.
- Ability to work a flexible schedule including overtime, holiday, and weekends which will vary depending on company needs.
- Must be a self-starter with the ability to stay motivated and on task.
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, on-site gym, and other wellness perks.