Job description
Location: Somerville, MA
At Viral Vector Services (VVS) a division of Thermo Fisher Scientific we deliver, from process development through commercial supply, we offer the expertise and resources vital to help clients deliver innovative gene therapies. Placed in the forefront of our leading and innovative Cell and Gene Therapy business enabling clients to cure genetic, rare, and otherwise untreatable diseases
How will you make an impact?
The Quality Specialist I, Document Control will participate in the day to day operations related to document review, approval, and control and release functions in the Document control department.
What will you do?
- Ensures documents meet company standards and regulatory requirements
- Supports and processes all document workflow types to support the business
- Coordinates and verifies original data for archiving in accordance with SOPs
- Ensures that records and data removed from archive room are removed per procedure
- Maintains archive databases and electronic records
- Controls transfer and retrieval of documents to/from external contract archive (iron mountain)
- Maintains cleanliness and organization of archive room to ensure audit and inspection readiness
- Assists with document retrieval for audits/inspections
- Assist with the improvement of quality compliance by recognizing continuing issues and bringing them to QA management’s attention
- Supports Client and Regulatory Audits, when needed
- Capable of interpreting and applying company standard operating procedures and policies and in work situations.
How will you get here?
- High School diploma or Associate degree in science
- Minimum of 1 year of appropriate experience in GMP regulated environment.
- Excellent written and oral communication skills.
- Strong computer skills including Microsoft Word, Excel, and Access.
- Must be able to quickly learn new software
- Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
- Must be fluent in English
Incredible Benefits!
- Review our company’s Total Rewards
- Medical, Dental, & Vision benefits – Effective Day 1
- Paid Time Off & Holidays
- 401K Company Match up to 6%
- Tuition Reimbursement – Available after 90 Days!
- Employee Referral Bonus
- Employee Discount Program
- Employee Recognition Program
- Charitable Gift Matching
- Company Paid Parental Leave
- Career Advancement Opportunities
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our global team of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
ACCESSIBILITY/DISABILITY ACCESS
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
- This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
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