QA Operations Specialist II

Maravai LifeSciences; San Diego (CA); On-site; USD 60,000 - 70,000; Full time

Benefits offered by this job

RSU equity

Employee stock purchase plan

Medical plans and HSA/FSA

Fertility assistance

Retirement contributions

Paid holidays

Job summary

Maravai LifeSciences is hiring a QA Operations Specialist II to maintain and improve the Quality Management System. You will review deviations, NCRs, CAPAs, and supplier management, with responsibility for change controls and controlled documentation.

You will monitor quality metrics and ensure compliance with ISO 9001:2015 and related standards. The role requires a bachelor’s degree in a scientific discipline and at least 5 years in a life science setting, with strong communication and

Qualifications

• Bachelor's degree in science required.
• Minimum 5 years of experience in life science industry.
• Knowledge of ISO 9001 (or ISO 13485).
• Strong verbal and written communication skills.
• Strong interpersonal and teamwork skills.
• Strong problem-solving and analytical abilities for investigations.
• Self-motivated with ability to organize and prioritize multiple tasks.
• Proficient in Microsoft Office; NetSuite ERP and MasterControl a plus.

Responsibilities

• Review and approve Quality Events (deviations, NCRs, CAPAs, complaints) ensuring investigations are timely.
• Ensure Change Control of materials, equipment, processes, and procedures with proper documentation.
• Assist with document and record control functions as needed.
• Oversee training programs and deliver quality-related training.
• Conduct quality investigations to identify root causes and preventive actions; track effectiveness.
• Lead cross-functional risk identification and mitigation activities.
• Review and approve product documentation for disposition of finished goods.
• Compile, maintain and report quality metrics including weekly/monthly/quarterly trends.
• Participate in internal and external quality audits as needed.

Skills

Quality Assurance

ISO 9001/13485

GxP Knowledge

Root Cause Analysis

Documentation Control

Audits

Cross-functional teamwork

Quality Metrics

Training Oversight

Education

Bachelor's Degree in Science

Tools

NetSuite ERP

MasterControl

Microsoft Office

Job description

Who we are:

Maravai LifeSciences translates extraordinary science into everyday miracles, helping biotech, biopharma, and life sciences companies everywhere deliver novel vaccines, therapeutics, and diagnostics. We are global leaders in providing products and services within the fields of nucleic acid production and biologics safety testing to many of the world's leading biopharma, vaccine, diagnostics, and cell and gene therapy companies.

At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitableculture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together, providing differentiated value to our customers, and enabling the miracles of science. For over 35 years, Maravai's portfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since its inception, we are now leading the way in the rapidly expanding mRNA market.

Your next role as a Miracle Maker

Maravai LifeSciences is seeking a #MiracleMaker to join our Quality Assurance team as a QA Operations Specialist II. The QA Operations Specialist II is responsible for the maintenance and continuous improvement of the Quality Management System. Includes the review and approval of deviations, NCRs, CAPAs, supplier management, change controls, and controlled documentation management, etc. Provides review and approval for products and new product development documentation. Tracks and reports on quality metrics. Ensures compliance with company policies and procedures and applicable domestic and international standards and regulations, including but not limited to ISO 9001:2015.

How you will make an impact:

• Responsible for reviewing and approving Quality Events (e.g. deviations, NCRs, CAPAs, and complaints) to ensure appropriate investigations are completed timely.
• Ensures Change Control of materials, equipment, processes, procedures include appropriate documentation.
• Assists with document and record control functions as needed
• Provides oversight for training program and conduct quality related training
• Conducts quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness. Use of quality tools, such as 5-Why's, FMEA's, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
• Leads cross-functional teams in risk identification and mitigation activities.
• Reviews and approves product documentation for disposition of finished goods.
• Compiles, maintains, and reports quality metrics to ensure visibility of QMS health, including creating trending graphs for weekly, monthly, and quarterly reports.
• Participates in the audit program, including conducting internal audits and external quality audits, as needed (e.g. customers, ISO, etc.).
• Assures compliance with all in-house or external specifications to standards such as ISO or customer requirements.
• Work with various functions, including Manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT, etc. to continuously improve the Quality Management System.
• Supports supplier quality by maintaining the approved supplier list, administering supplier surveys, quality agreements, approved supplier list, and performing critical supplier audits as needed.
• Leads Quality improvement projects.
• Identifies quality issues/ discrepancies and effectively resolve these within the organization.
• Perform other functions and duties as required.

The skills and experience that you will bring:

• Minimum, Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.).
• Quality professional with a minimum of 5 years relevant experience in a life science industry.
• Requires knowledge of ISO 9001 standards (or ISO 13485)
• Strong and effective verbal and written communication skills.
• Strong interpersonal, teamwork and customer interfacing skills.
• Strong problem-solving skills and analytical skills applied to investigations.
• Self-motivated and able to organize and prioritize multiple tasks.
• Ability to identify quality issues/discrepancies and effectively resolve discrepancies within the organization.
• Proficient in Microsoft Office
• Experience with NetSuite ERP and MasterControl is a plus

The anticipated salary range for this position is $60,000 - $70,000. In addition, highly competitive long-term incentives in the form of company equity, bonus participation and company sponsored benefits are provided as part of the total compensation package. The salary offer will depend on multiple factors which may include the successful candidate's skills, experience and other qualifications, as well as the location of the role.

LI-Onsite

The benefits of being a #MiracleMaker:

• You have the potential to change, improve, and save lives around the world.
• You have the opportunity to be a part owner in Maravai through RSU grants and optional employee stock purchase plans.
• We offer comprehensive medical plans and HSA/FSA options.
• Fertility & family planning assistance.
• A variety of additional optional benefits and insurance options, including pet insurance.
• Retirement contributions.
• Holidays & Paid Time Off.

Benefits may vary by region and employment type and do not apply to temporary employees or contractors. See a comprehensive list of benefits at our Benefits & growth site at https://www.maravai.com/careers/benefits-and-growth/

To view more opportunities to become a #MiracleMaker, visit our career site at https://www.maravai.com/careers/

Maravai LifeSciences is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation, and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.