TriLink BioTechnologies, part of Maravai LifeSciences
Senior QA Operations Specialist
TriLink BioTechnologies, part of Maravai LifeSciences, San Diego, California, United States, 92189
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 equitable culture 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.
Your next role as a Miracle Maker Maravai LifeSciences is seeking a #MiracleMaker to join our QA Operations team as a Senior QA Operations Specialist. As a Senior QA Operations Specialist, you'll be responsible for leading the maintenance and continuous improvement of the Quality Management System. This 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 including appropriate documentation
Maintains the control of documents and records
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, reports, and presents quality metrics during site Quality Management Reviews to ensure visibility of QMS health, including creating trending graphs for weekly, monthly, and quarterly reports
Leads the audit program, including conducting internal audits and hosting external or third party quality audits (e.g. customers, ISO, etc.)
Ensures compliance with all in-house or external specifications to standards such as ISO or customer requirements
Works 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 resolves these within the organization
Performs 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 $102,000- $115,000. 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/.
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.
Seniority level Mid-Senior level
Employment type Full-time
Job function Quality Assurance
Industries Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Chemical Manufacturing
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At Maravai, we believe that diverse perspectives are the foundation of innovation. Through an inclusive and equitable culture 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.
Your next role as a Miracle Maker Maravai LifeSciences is seeking a #MiracleMaker to join our QA Operations team as a Senior QA Operations Specialist. As a Senior QA Operations Specialist, you'll be responsible for leading the maintenance and continuous improvement of the Quality Management System. This 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 including appropriate documentation
Maintains the control of documents and records
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, reports, and presents quality metrics during site Quality Management Reviews to ensure visibility of QMS health, including creating trending graphs for weekly, monthly, and quarterly reports
Leads the audit program, including conducting internal audits and hosting external or third party quality audits (e.g. customers, ISO, etc.)
Ensures compliance with all in-house or external specifications to standards such as ISO or customer requirements
Works 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 resolves these within the organization
Performs 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 $102,000- $115,000. 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/.
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.
Seniority level Mid-Senior level
Employment type Full-time
Job function Quality Assurance
Industries Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Chemical Manufacturing
#J-18808-Ljbffr