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Lead Document Control Specialist
$91K - $130K/yr(employer-provided)
↑4 30d
Description
About Genetix Biotherapeutics
At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:
Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.
SUMMARY
The Lead Document Control Specialist is considered an expert in their knowledge of Document Control processes, who possesses broad knowledge and can lead multiple projects with a high degree of independence.
This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.
RESPONSIBILITIES
- Maintain the document control system, including lifecycle management of paper and electronic records
- Review new and revised controlled documentation for appropriate format, content and consistency with other documentation and compliance to document control procedures
- Lead the development of document review standards & conventions
- Drive improvements and efficiencies with a high degree of initiative and independent judgement related to the document management process, including system updates
- Lead the development of templates, tools and procedures for the global Document Control function
- Contribute to innovative solutions to create efficiencies and educate the customer base
- Serve as Subject Matter Expert and Qualified Trainer of SOP Development and other instructor led courses
- Manage the indexing, storage and retrieval of records within the QA Archive and at off-site document storage facility/ies
- Work with stakeholders and customers to ensure appropriate document management, use, standards application and control
- Provide support for all documentation control activities
- Provide support during audits of regulatory agencies; Other duties as assigned
QUALIFICATIONS
- BS/BA with 5-7+ years of document control experience supporting documentation programs and systems in pharmaceutical or biopharmaceutical industries.
- Technical writing experience a plus; expertise in SOP Development and the ability to train personnel on related concepts
- Strong knowledge GxP regulations, quality systems (Document Control, Training)
- Must have excellent attention to detail, project and time management skills as well as the ability to manage multiple priorities with aggressive timelines with minimal supervision
- Excellent interpersonal, teamwork, and organizational skills
- Expert proficiency with Microsoft products and document publishing software (e.g. Excel and Adobe Pro); must be able to learn additional applications as needed. Veeva QDocs experience is a plus.
Additional Information
The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.
Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.
Pay Transparency
$91,000—$130,000 USD
Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
Genetix Biotherapeutics
BIOTECHNOLOGY
Gene Therapy, Cellular Extraction & Reintroduction
LocationMA - Somerville
Open Jobs20
This listing was originally posted on Genetix Biotherapeutics's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.