QA Operations Specialist II
TriLink BioTechnologiesSan Diego, California, United States · Posted 1 month agoDescription
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 ensure appropriate investigations are completed 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.
- Work with 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, expe
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