Aspen Neuroscience is seeking a driven, detail oriented, and collaborative Quality Systems Manager to join our Quality team. This role is fully responsible for the management and administration of the company’s Quality Systems, including training and document control. In addition, will be responsible of onboarding activities for new employees on the Quality department side. We are looking for top talent with exceptional organization skills and a desire to learn and grow to join this highly dynamic and patient-focused team with a commitment to excellence. This role reports to our Director, Quality Assurance and is an onsite position located in San Diego, CA. This role requires a high degree of on-site collaboration. At this time, we are not considering fully remote applicants.
DUTIES AND RESPONSIBILITIES:
- Manages document control and training management and processes to ensure GxP compliance with internal policies and external regulations
- Supports the routing, review, approval, distribution, and archiving of new and revised controlled documents
- Develops, revises, and reviews procedures and other controlled documents
- Collaborates with cross-functional team members to author and revise controlled documents
- Provides support during regulatory inspection • Prepares status reports for document control, training, and quality systems for Quality Management review
- Manages, monitors, reviews, and approves quality events and associated workflows, including GxP documentation • Support vendor management program
- Support validation activities for GxP systems
- Perform new hire orientation and training
- Perform data-entry and reconcile legacy and active training files
- Oversee and support, in conjunction with Systems and applicable cross-functional teams, the management of company’s validated GxP computerized systems, including risk assessments
EDUCATION AND EXPERIENCE:
- Bachelor's degree or a combination of relevant education and applicable job experience.
- Minimum of 4 years’ experience within FDA regulated industry
- Experience working with Electronic Documentation Management Systems (EDMS), Learning Management System (LMS), and Quality Management System (QMS)
- Direct experience developing and maintaining document control, training management and quality management systems
- Experience with cGMP regulated environment
- Experience authoring SOPs, protocols, and reports
JOB SPECIFICATIONS:
- Excellent writing and editing skills with strict attention to detail to meet compliance requirements
- Ability to work on multiple assignments in collaboration with cross functional team members
- High level of initiative in a fast-paced environment.
- Very detail-oriented and organized.
- Ability to work in teams as well as independently.
- Strong written and verbal communication skills.
- Advanced Microsoft Office 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, onsite gym, and other wellness perks.
The anticipated salary range for candidates who will work in San Diego is $100K to $160K annually. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the industry, education, etc. Aspen Neuroscience is multi-state employer, and this salary range may not reflect positions that work in other states.