QA Operations Specialist II

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

Benefits offered by this job

RSU grants

Equity options

Medical plans and HSA/FSA

Fertility & family planning

Retirement contributions

Holidays & Paid Time Off

Job summary

Maravai LifeSciences is seeking a QA Operations Specialist II to maintain and improve the Quality Management System. You will review deviations, NCRs, CAPAs, supplier management, change controls, and documentation, ensuring compliance with domestic and international standards including ISO 9001:2015.

You will lead quality events, oversee training, and drive cross-functional quality improvements while collaborating with Manufacturing, QC, R&D, and other teams to uphold quality operations.

Qualifications

• Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.).
• 5+ years relevant experience in a life science industry.
• Knowledge of ISO 9001 standards (or ISO 13485).
• Strong verbal and written communication skills.
• Interpersonal, teamwork, and customer interfacing skills.
• Ability to identify quality issues/discrepancies and effectively resolve discrepancies.

Responsibilities

• Review and approve Quality Events (e.g., discovery events) and CAPAs to ensure investigations are completed in a timely manner.
• Provide oversight for quality operations training program and conduct quality-related training.
• Conduct quality investigations to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness.
• Lead cross-functional teams in risk identification and mitigation activities.
• Review and approve product documentation for disposition of finished goods.
• Review and approve change controls of materials, equipment, processes, and procedures including documentation.
• Maintain control of documents and records.
• Ensure compliance with ISO standards and customer requirements.
• Collaborate with Manufacturing, QC, R&D, commercial, customer service, facilities, IT, and others to improve Quality Operations.
• Lead Quality improvement projects.
• Identify quality issues and resolve discrepancies within the organization.
• Manage document change orders and update procedures and forms as required.
• Review stability protocols and packets as necessary.
• Review finished good specifications.

Skills

Quality professional

Communication skills

Problem-solving

Microsoft Office

NetSuite ERP

MasterControl

Teamwork

Self-motivation

Organizational skills

Education

Bachelor's degree in scientific discipline

Tools

NetSuite ERP

MasterControl

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.

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.discovery events and CAPAs) to ensureappropriate investigationsarecompleted in a timely manner.
• Provide oversight for quality operations training program and conducts quality related training.
• Conduct 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.
• Lead cross-functional teams in risk identification and mitigation activities.
• Review and approve product documentation for disposition of finished goods.
• Review and approve change controls of materials, equipment, processes, and procedures including appropriate documentation.
• Maintain the control of documents and records.
• Assure compliance with all in-house or external specifications to standards such as ISO or customer requirements.
• Workwith various functions, including Manufacturing, QC, R&D, commercial, customer service, technical support, facilities, IT, etc. to continuously improve Quality Operations.
• Lead Quality improvement projects.
• Identify quality issues/discrepancies and effectively resolve these issues within the organization.
• Manage document change orders and work with respective manufacturing and other teams to update procedures, work instructions, and forms as required.
• Review stability protocols and packets as necessary.
• Review finished good specifications.
• Participate in project initiatives at the site as a quality representative.
• Participate in internal and external audits as required.
• Ensure compliance with GDP practices.
• Promote a culture of quality, compliance, continuous improvement, and inspection readiness throughout 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.

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/

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.