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Document Control Associate II

TriLink BioTechnologiesSan Diego, California, United StatesOnsite

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 Document Control Associate II. This role involves maintaining the document and record control systems, ensuring they meet Quality Management System (QMS) requirements. This position also oversees the coordination of issuance, revision, review, and approval of SOPs and other documents.

How you will make an impact:


  • Issue document change order numbers, route and track new and revised documents for approval, file controlled documents and other documentation provided to QA, and ensure that all documentation follows the change control procedures
  • Review documents for completeness, adherence to company guidelines on formatting, and authorization for approvals
  • Monitor status of in-process document changes to ensure timely completion
  • Organize filing systems for electronic and paper based GMP/research documents
  • Facilitate the establishment and improvement of quality systems
  • Facilitate continuous improvements efforts of quality systems
  • Assist in quality audits, including document preparation and record retrieval.
  • Update and maintain quality metrics as needed
  • Perform other functions and duties as required

The skills and experience that you will bring:


  • BS Degree in scientific area preferred.
  • Minimum of 3-5 years hands-on experience with document control management, preferably in a life science industry
  • Demonstrated ability to work independently and as part of a team
  • Experience with ISO 9001, ISO 13485, 21CFR820, 21CFR 211, or other regulated industry a plus.
  • Experience with MasterControl or other document management system a plus but not required.
  • Good writing skills, high degree of organization and excellent attention to detail.
  • Good computer skills with working knowledge of MS office suite and Adobe Acrobat.
  • Must be able to support after hours and weekend as needed.
  • Self motivated and able to organize and prioritize mulitple tasks.

  • Issue document change order numbers, route and track new and revised documents for approval, file controlled documents and other documentation provided to QA, and ensure that all documentation follows the change control procedures
  • Review documents for completeness, adherence to company guidelines on formatting, and authorization for approvals
  • Monitor status of in-process document changes to ensure timely completion
  • Organize filing systems for electronic and paper based GMP/research documents
  • Facilitate the establishment and improvement of quality systems
  • Facilitate continuous improvements efforts of quality systems
  • Assist in quality audits, including document preparation and record retrieval.
  • Update and maintain quality metrics as needed
  • Perform other functions and duties as required

The skills and experience that you will bring:


  • BS Degree in scientific area preferred.
  • Minimum of 3-5 years hands-on experience with document control management, preferably in a life science industry
  • Demonstrated ability to work independently and as part of a team
  • Experience with ISO 9001, ISO 13485, 21CFR820, 21CFR 211, or other regulated industry a plus.
  • Experience with MasterControl or other document management system a plus but not required.
  • Good writing skills, high degree of organization and excellent attention to detail.
  • Good computer skills with working knowledge of MS office suite and Adobe Acrobat.
  • Must be able to support after hours and weekend as needed.
  • Self motivated and able to organize and prioritize mulitple tasks.

The anticipated salary range for this position is $27.75 - $31.50 per hour.  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 part owner in Maravai through RSU grants and optional employee stock purchase plans.
  • We offer comprehensive medical plansand HSA/FSAoptions.
  • 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.

Life at TriLink BioTechnologies

TriLink BioTechnologies, part of Maravai LifeSciences, is a best-in-class contract development and manufacturing organization (CDMO) for the synthesis of nucleic acids, NTPs and mRNA capping analogs. TriLink has scale-up expertise and unique mRNA, oligonucleotide & plasmid production capabilities for companies focused on therapeutic, vaccine, diagnostic and biopharmaceutical breakthroughs. Biopharma companies turn to TriLink as a critical supplier of modified nucleic acids and as a CDMO partner to help them move from early research into clinical trials. TriLink's proprietary CleanCap® mRNA co-transcriptional capping technology simplifies mRNA manufacturing by removing additional enzymatic steps, resulting in high capping efficiency and improved yields over traditional co-transcriptional capping methods. TriLink's CDMO services offer a range of manufacturing grade products from discovery-grade (RUO) to its customizable intermediate-grade - GMPLink™ to full GMP-grade with scale-up and technology transfer expertise. With its recent facility expansion to increase cGMP capacity, TriLink provides support from initial research phases to the production of material for use in clinical trials. TriLink operates a quality system in compliance with ICH Q7, Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Section 19, APIs for Use in Clinical Trials, and ISO 9001:2015 standards. TriLink, founded by Dr. Rick Hogrefe and Terry Beck, has been a pioneer in nucleic acid synthesis & manufacturing since its inception in 1996. With product and service offerings and expertise that have adapted to customer needs over the decades, TriLink remains committed to taking on challenges others simply will not. TriLink continues to expand its cGMP and general mRNA, oligonucleotide & plasmid manufacturing capacity at its new San Diego global headquarters to support therapeutic, vaccine and diagnostic customers.
Thrive Here & What We Value- Inclusive and Equitable Culture- Collaborative work environment- Opportunities for professional growth and development- Flexible work schedule options- Recognition for outstanding performance- Diverse perspectives as the foundation of innovation- Providing differentiated value to customers- Enabling miracles of science- Comprehensive medical plans and HSA/FSA options- Retirement contributions, Holidays & Paid Time Off (varies by region)
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