Quality Assurance Associate

Position Overview:

The Quality Assurance Associate will provide support for internal and external activities to support GxP operations. This role’s primary functions include management of training, electronic systems document control, coordination of periodic review of SOPs, the approved supplier/vendor qualification schedule, maintenance of electronic tracking systems for GMP supplier analytical documentation, review of release and stability data and notifying management of trends, tracking the status of quality agreements and product quality complaints, and participating in internal audits of Vistagen’s Quality Systems and Records.

This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to the Senior Manager, Quality Assurance.

Key Duties & Responsibilities:

Key responsibilities of this role include, but are not limited to:

• Training - Ensure all GxP training records and training matrices are available and maintained. Manage the electronic training tracker. Conduct training of Vistagen personnel on standard operating procedures if requested by Quality management. Coordinate new employee training with affected departments, Human Resources and Quality Assurance.
• Document Control - Maintain electronic document change control logs, route of documents to personnel for review and approval, coordinate periodic SOP reviews and ensure its completion, and archive obsoleted documents. Send out training notices to employees and consultant(s) for new and revised standard operating procedure as well as send follow-up training reminders as needed.
• Quality Operations - Maintain electronic trackers related to deviations, change controls, CAPA, Out of Specification investigations, product complaints, following up on open records to ensure timely completion. 
• Analytical Quality Support - Attend and participate in calls with Vistagen GMP suppliers. Track progress of the review and approval of analytical method transfers, method validations, laboratory and out of specification investigations. Maintain records of GMP documentation in Vistagen’s electronic data storage platform. Review stability data and notify Quality management of trends and out of specification results. 
• GxP Supplier / Vendor Management - Maintain supplier/vendor qualification schedule and the Approved Supplier List for GMP and GCP suppliers and vendor. Track the status approval status and expiration of supplier Quality Agreements and notify Quality management of upcoming expirations.
• Product Quality Complaints – Maintain electronic trackers of product complaints. Coordinate with Vistagen’s Chemistry, Manufacturing and Controls (CMC) and Clinical Supply team to collect complaint documentation. Ensure that electronic folders housing complaint documentation are complete.
• Internal Audits – Assist in conducting internal audits of Vistagen’s quality systems and records. Maintain the internal audit schedule and audit records. 
• Other Duties – Other Quality Assurance tasks may be assigned by Quality management as needed.

Qualifications:

• Bachelor's degree preferably in a scientific or technical discipline; advanced degree preferred.
• Minimum 5 years of experience in analytical chemistry methods with preference for nasal spray experience, analytical method validation, stability data review, and out of specification investigations. 
• 2 years of experience with the Veeva Quality Docs platform.
• Experience with DocuSign Part 11.
• Experience with data storage platforms such as Box GxP.
• Experience using Microsoft Excel and Word.
• Strong team player that has a customer service approach and is solution oriented.
• Strong attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Strong written and verbal communication and presentation skills.
• Ability to work independently in a remote setting.

Compensation and Benefits

What we offer:

• Industry competitive compensation
• Performance-based bonuses
• Stock options
• Employee Stock Purchase Plan
• 401k plan
• A collaborative and innovative work environment at the forefront of biotech advancements

Give your best, live wholesomely:

• Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents
• FSA and HAS
• Basic Life Insurance 2x Earnings and AD&D
• Employee Assistance Program
• Healthcare advocates group to help navigate the healthcare system

Work-life balance:

• Unlimited paid time off
• Flexible work schedule
• Remote work option
• Paid holidays
• Mental health days
• Winter shutdown
• Casual work environment

We uphold the ethos of work-life harmony, where enjoyment is woven into our fundamental values of integrity, teamwork, compassion, and excellence.

The anticipated salary range for candidates who will work remotely is $105,000-$130,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc.

Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company’s 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. 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 talk or hear. The employee is frequently required to sit.

The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often.

Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

This position requires the ability to lift and/or move up to 25 pounds occasionally.

Evening and weekend work as necessary. Flexible hours (domestic time zones) may be required in this remote environment.

DISCLAIMER

The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification as well as general description of benefits and other compensation and it is not a substitute for applicable plan documents or company policies. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

EEO Employer: VISTAGEN THERAPEUTICS, INC., is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected classification.

All Employee’s have rights under Federal Employment Laws and link to the three posters: Family and Medical Leave Act (FMLA) Poster Know Your Rights Poster; and Employee Polygraph Protection Act (EPPA)

OVERVIEW OF THE COMPANY

Headquartered in South San Francisco, CA, Vistagen Therapeutics, Inc. (NASDAQ: VTGN) is a late clinical-stage company leveraging its pioneering neuroscience and deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of intranasal product candidates called pherines. Each pherine product candidate in Vistagen’s neuroscience pipeline is designed to rapidly activate olfactory system and rain neurocircuitry to achieve desired therapeutic benefits and differentiated safety without requiring systemic absorption or binding to neurons in the brain. Vistagen’s neuroscience pipeline also includes an oral prodrug, AV-101, with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent disorders, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at www.vistagen.com.

Salary : $105,000 - $130,000