QA Associate II

RiseMe; San Diego (CA); On-site; USD 76,000 - 92,000; Full time

Benefits offered by this job

Medical/Dental insurance

Onsite gym

Paid time off

Job summary

Aspen Neuroscience, Inc. in San Diego, CA, is seeking a Quality Assurance Associate II to ensure cGMP-compliant manufacturing and documentation. You will review batch records, support deviations, CAPAs, and change controls, and collaborate across Manufacturing, QC, Facilities, and Supply Chain.

Qualified candidates have a Bachelor's in biological sciences with GMP experience; aseptic technique and cleanroom exposure are a plus. This on-site role requires flexibility for weekend/holiday work.

Qualifications

• Bachelor’s degree in biological sciences or related field with GMP manufacturing experience.
• Experience in GMP/GLP regulated environments is required.
• Aseptic technique and environmental monitoring experience is a plus.
• ISO 5/ISO 7 cleanroom experience is a plus.

Responsibilities

• Review batch records, analytical test results, environmental monitoring data, deviation records, and other quality documentation to support disposition of raw materials and product lots.
• Assess and support timely closure of deviations, CAPAs, investigations, change controls, and nonconformances per procedures.
• Perform independent review of GMP documentation and coordinate correction of documentation errors or omissions.
• Conduct QA line clearance inspections, housekeeping assessments, and manufacturing process observations to verify compliance with procedures.
• Apply established quality standards to make routine quality decisions and elevate issues requiring review.
• Support release of raw materials, equipment and supplier qualification activities.
• Participate in internal and external audits by providing documentation and quality support.
• Contribute to quality investigations and CAPA activities by gathering information and supporting actions.

Skills

Quality Systems

Documentation Review

Problem Solving

Attention to Detail

Collaboration

Communication

Adaptability

Technical Proficiency

Cleanroom

Schedule Flexibility

Education

Bachelor's degree in biological sciences or relevant field

Tools

Microsoft Office

Electronic Quality Management Systems

Job description

The Quality Assurance Associate II supports Quality Assurance operations by ensuring materials, processes, and products are manufactured and documented in compliance with current Good Manufacturing Practices (cGMP) and company procedures. This role applies professional quality principles to routine and moderately complex quality activities, exercises judgment within established guidelines, and collaborates cross-functionally to support product quality and compliance. Work is performed with minimal day-to-day supervision and general guidance on new or complex assignments. This is an on-site role in Torrey Pines, CA that requires flexibility and availability for weekend and holiday work as needed. Relocation is not available.

DUTIES AND RESPONSIBILITIES:

• Review manufacturing batch records, analytical test results, environmental monitoring data, utility data, deviation records, and other quality documentation required to support the disposition of raw materials and manufactured product lots.
• Assess and support the timely closure of deviations, discrepancies, CAPAs, laboratory investigations, change controls, and nonconformance records in accordance with established procedures.
• Perform independent review of GMP documentation and coordinate correction of documentation errors or omissions, as needed.
• Conduct QA line clearance inspections, housekeeping assessments, and manufacturing process observations to verify compliance with approved procedures.
• Apply established quality standards and procedures to make routine quality decisions and elevate issues requiring additional review.
• Support the release of raw materials, equipment and supplier qualification activities.
• Participate in internal and external audit activities by providing documentation, information, and quality support.
• Contribute to quality investigations and change control activities by gathering information, performing assessments, and supporting implementation of corrective and preventive actions.
• Assist in maintaining quality systems and identifying opportunities for process improvements that enhance compliance and operational effectiveness.
• Provide process guidance and training to personnel on documentation and quality system requirements Identify potential compliance concerns and elevate issues to appropriate quality leadership for resolution.
• Draft, revise, and review standard operating procedures (SOPs), forms, and manufacturing documentation in accordance with established document control practices.
• Collaborate effectively with Manufacturing, QC, Facilities, Supply Chain, and other functional groups to support quality objectives

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in biological sciences or relevant field with minimum 2 years of GMP manufacturing experience.
• Experience working in a regulated environment (GMP, GLP) is required. Experience applicable to cell therapies is a plus.
• Experience in aseptic technique, drug safety testing, and environmental monitoring is a plus.
• Experience in controlled (ISO 5/ISO7) clean room environments is a plus.

JOB SPECIFICATIONS:

• Quality Systems Knowledge: Working knowledge of cGMP regulations, quality principles, and company procedures to support compliant manufacturing and quality operations.
• Documentation Review: Strong proficiency in reviewing GMP documentation, identifying discrepancies, and ensuring accurate, complete, and compliant records.
• Problem Solving: Sound judgment in evaluating routine and moderately complex quality issues, applying established procedures, and elevating concerns when appropriate.
• Attention to Detail: Meticulous approach to record review, investigations, and quality documentation with a focus on accuracy and consistency.
• Collaboration: Demonstrated effectiveness in building productive relationships across varying department teams to resolve issues and achieve shared objectives.
• Communication: Effective verbal and written communication skills, including documentation, training support, and cross-functional interactions.
• Adaptability: Comfortable managing competing priorities and adjusting to changing business needs in a fast-paced environment.
• Technical Proficiency: Experience using Microsoft Office applications and electronic quality management systems within a regulated environment.
• Cleanroom Operations: Qualified or capable of becoming qualified to work in controlled cleanroom environments while maintaining gowning certification requirements.
• Schedule Flexibility: Willingness to support manufacturing operations through flexible scheduling, including occasional evenings and weekends during production campaigns.

WORKING CONDITIONS

Office and Lab environment. While performing the duties of this Job, the employee is

frequently exposed to toxic or caustic chemicals. This is an indoor position requiring the

ability to perform experiments in the laboratory, and type and use a computer. May work in Cleanroom for an extended period of time.

PHYSICAL DEMANDS

While performing the duties of this Job, the employee is Occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. These work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodation may be made to enable people with disabilities to perform the essential functions of the job.

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. Aspen is not able to provide visa sponsorship for this role. Applicants must have valid work authorization that does not require employer sponsorship now or in the future.

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 $75,600 - $92,400 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.