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Part-Time Document Control Associate I
Стабильная компания в растущем секторе биотехнологий с хорошим пакетом льгот (даже для частичной занятости, включая RSU). Однако позиция является узкоспециализированной и предполагает работу по выходным.
Сложность вакансии
Позиция начального уровня (Associate I), требующая 1-2 года опыта. Основная сложность заключается в необходимости строгого соблюдения регуляторных стандартов (ISO/CFR) и высокой внимательности к деталям.
Анализ зарплаты
Указанная роль является позицией начального уровня с частичной занятостью. Рыночные оценки для полной занятости в этой области в США составляют $45k-$60k, соответственно, почасовая ставка для Part-Time будет пропорциональна этому диапазону.
Сопроводительное письмо
I am writing to express my interest in the Part-Time Document Control Associate I position at Maravai LifeSciences. With a solid background in document control and a keen eye for detail, I am eager to contribute to your Quality & Regulatory team. My experience in maintaining document change orders and ensuring compliance with Quality Management Systems aligns perfectly with the responsibilities outlined in the job description.
During my previous roles, I have developed a strong proficiency in managing SOPs and coordinating the review and approval processes for critical documentation. I am particularly impressed by Maravai's commitment to innovation in the mRNA market and biologics safety testing. I am confident that my organizational skills and familiarity with regulated environments will allow me to effectively support your quality systems and continuous improvement efforts.
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Откликнитесь в maravailifesciences уже сейчас
Присоединяйтесь к команде Maravai LifeSciences и станьте частью инноваций в сфере биотехнологий, обеспечивая высочайшие стандарты качества!
Описание вакансии
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 & Regulatory team as a Part-Time Document Control Associate I. As a Part-Time Document Control Associate I, you will be responsible for maintaining the document and record control systems and ensuring they meet Quality Management System (QMS) requirements. This position is responsible for coordinating the 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
- Support 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
- Support after hours and weekends 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 1-2 years hands-on experience with document control management, preferably in a life science industry
- 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.
- Demonstrated ability to work independently and as part of a team
- 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 multiple tasks.
#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.
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Навыки
- Document Control
- Quality Management System
- S&OP
- ISO 9001
- ISO 13485
- MasterControl
- Adobe Acrobat
- Microsoft Office
- Quality Assurance
Возможные вопросы на собеседовании
Проверка понимания жизненного цикла документа в регулируемой среде.
Опишите процесс управления изменениями (Change Control): от инициации запроса до архивации старой версии документа.
Оценка опыта работы с отраслевыми стандартами качества.
Работали ли вы ранее со стандартами ISO 9001 или ISO 13485? Какие основные требования к документации они предъявляют?
Выявление навыков приоритизации в условиях многозадачности.
Как вы распределяете задачи, если одновременно поступает несколько срочных запросов на выдачу номеров изменений и проверку SOP?
Проверка внимательности к деталям, критически важной для QA.
Расскажите о случае, когда вы обнаружили ошибку в документе, который уже прошел несколько стадий согласования. Каковы были ваши действия?
Оценка готовности к специфическому графику.
Вакансия предполагает поддержку в нерабочее время и выходные. Готовы ли вы к такому графику и как это повлияет на вашу работу?
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