QA Operations Specialist II

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

Benefits offered by this job

RSU grants

Employee stock purchase plan

Comprehensive medical plans

HSA/FSA options

Fertility & family planning assistance

Pet insurance

Retirement contributions

Holidays & Paid Time Off

Job summary

Maravai LifeSciences is seeking a QA Operations Specialist II to join our Quality Assurance team. This role focuses on maintaining and improving the Quality Management System, reviewing deviations, NCRs, CAPAs, supplier management, change controls, and controlled documentation to ensure compliance with ISO 9001:2015.

You will lead cross-functional quality investigations, train operation teams, and drive continuous improvement across Manufacturing, QC, R&D, and other functions to uphold quality,

Qualifications

• Bachelor’s degree in a scientific discipline (Chemistry, Biology, etc.).
• Minimum 5 years in a life sciences quality role.
• Knowledge of ISO 9001 or ISO 13485 is required.
• Strong verbal and written communication skills.
• Experience with quality investigations and CAPAs.

Responsibilities

• Review and approve Quality Events and CAPAs to ensure timely investigations.
• Oversee quality training programs and conduct quality-related training.
• Lead quality investigations to determine root cause and effectiveness.
• Coordinate cross-functional risk identification and mitigation.
• Review and approve documentation for disposition of finished goods.

Skills

Communication skills

Interpersonal skills

Problem solving

Analytical thinking

Prioritization

Microsoft Office

Teamwork

Education

Bachelor’s degree in a 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.

At Maravai, we believe that diverse perspectives are the foundation of innovation.Through an inclusive andequitableculture where every team member is inspired to bring their best selves to work, we cultivate an environment in which we can lead together,providingdifferentiated value to our customers, and enabling the miracles of science.For over 35 years,Maravai’sportfolio companies have served as a catalyst for innovative, lifesaving technology for humanity. Pioneering nucleotide research since itsinception, 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 eventsandCAPAs) to ensureappropriate investigationsarecompletedina timely manner.
• Provideoversight forquality operationstrainingprogramandconductsquality related training.
• Conductquality investigations to assess root cause, corrections, corrective actions, preventive actions, andmonitoreffectiveness.Use of quality tools, such as 5-Why’s, FMEA’s, DMAIC, Cause and Effect Diagrams, Process Mapping, etc.
• Leadcross-functional teams in risk identification and mitigation activities.
• Reviewandapproveproduct documentation for disposition of finished goods.
• Reviewand approvechange controlsof materials, equipment, processes, and procedures includingappropriate documentation.
• Maintainthe control of documents and records.
• Assurecompliance 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 improveQualityOperations.
• LeadQuality improvement projects.
• Identifyquality issues/discrepancies and effectivelyresolvetheseissueswithin the organization.
• Managedocumentchangeorders and work with respective manufacturing and other teams to update procedures, work instructions, and forms asrequired.
• Review stability protocols andpacketsas necessary.
• Reviewfinishedgood specifications.
• Participatein project initiatives at the site as a quality representative.
• Participate in internal and external audits asrequired.
• Ensure compliance with GDP practices.
• Promote a culture of quality, compliance, continuous improvement, andinspectionreadiness throughout the organization.
• Perform other functions and duties asrequired.

The skills and experience that you will bring:

• Minimum,Bachelor’s Degreein scientific discipline (Chemistry, Biology, Bioengineering, etc.).
• Quality professional with a minimum of 5 years relevant experience ina lifescience 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 toidentifyquality issues/discrepancies and effectively resolve discrepancies within the organization.
• Proficient in Microsoft Office.
• Experience with NetSuite ERP andMasterControlis 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 partowner inMaravai through RSU grants andoptionalemployee stock purchase plans.
• Weoffer comprehensivemedical plansandHSA/FSAoptions.
• Fertility &family planningassistance.
• A variety ofadditionaloptional benefitsand insurance options, includingpet insurance.
• Retirementcontributions.
• 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 viewmoreopportunitiesto become a #MiracleMaker,visitour career site at https://www.maravai.com/careers/

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

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