What are the responsibilities and job description for the QA Systems Specialist - Auditing position at TriLink BioTechnologies?

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 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. 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 Quality Systems Specialist. As a Quality Systems Specialist you will support Quality Systems functions by conducting internal and external audits, as well as supporting, reviewing and approving investigations for Quality Events (Deviations, Complaints and Nonconformances). You will support routine qualification, management, and monitoring of suppliers and external service providers. Ensure compliance with company policies and procedures and applicable domestic and international standards and regulations.

How you will make an impact :

Responsible for coordinating the qualification of suppliers and service providers, including issuing questionnaires, conducting supplier audits (both onsite and remote), maintaining supplier record files, and administering the associated module in the electronic quality management system.
Responsible for supporting the internal audit program, including scheduling and conducting of audits.
Responsible for issuing internal and external audit findings to appropriate stakeholders, reviewing audit responses for adequacy, and for assigning and tracking associated action items to ensure timely completion.
Responsible for developing and maintaining tracking mechanisms to allow for quality event trending. Upon identification of adverse trends, collaborates with stakeholder departments to implement actions that will mitigate or eliminate any trends.
Support and / or lead change controls as needed.
Responsible for reviewing and approving quality investigations as needed to assess root cause, corrections, corrective actions, preventive actions, and monitor effectiveness.
Author and / or revise standard operating procedures.
Work with various functions, including Manufacturing, QC, R&D, Commercial, Customer Service, Technical Support, Facilities, IT, etc. to continuously improve the Quality Management System.
Assure compliance with all in-house or external specifications to standards, such as ISO and GMP regulations.
Responsible for collaborating with all departments to identify areas of improvement.
Perform other functions and duties as required.

The skills and experience that you will bring :

Bachelor's Degree in scientific discipline preferred (Chemistry, Biology, Biochemistry, etc.).

Quality professional with a minimum of 3 years of hands-on experience in quality assurance functions in the life sciences industry, including quality systems auditing, documentation review, investigation of quality events using various root cause analysis tools (such as 5 Whys, Fishbone, etc.), change control, supplier quality management, quality metrics reporting, and quality systems auditing

Auditor certification (such as ASQ CQA, ISO 9001, or Lead Auditor) preferred.

Knowledge of ISO standards (e.g., ISO 9001 or 13485) and cGMP regulations (e.g., ICH Q7, 21 CFR 210 / 211 / 11 / 820).

Strong verbal and written communication skills.

Strong analytical problem solving skills and attention to detail.

Strong interpersonal, teamwork, and customer interfacing skills.

Good computer skills with working knowledge of MS Office suite; additional experience using PowerPoint, Adobe Acrobat, ERP systems, and electronic quality management and document management systems (MasterControl a plus).

Self-motivated and able to organize and prioritize multiple tasks.

Ability to identify quality issues / discrepancies and effectively resolve across all levels of the organization.

Ability to travel approximately 25%-35% of the time.

Will work first shift (8am-5pm).

The anticipated salary range for this position is $62,950 - $69,500 annually. 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.

Click here to view Maravai LifeSciences Privacy Notice

HIRING SCAM ALERT

Recently, individuals impersonating Maravai LifeSciences Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that :

Maravai LifeSciences will never interview a candidate over RingCentral, similar messaging apps or social media (e.g. Telegram, Google Hangouts, WhatsApp, Facebook Messenger, etc.)

Maravai LifeSciences will never send a company check or ask an applicant to pay a fee or purchase at home work / training materials in connection with an application for employment.

Maravai LifeSciences will never provide excess money to an applicant and ask the applicant to write a check for repayment.

If you have any doubt about a job offer or any other communication purporting to come from Maravai LifeSciences, please reach out to us directly at taops@maravai.com. If you believe you have been a victim of fraud, you can report this activity at : www.iC3.gov or www.stopfraud.gov.

Salary : $62,950 - $69,500

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