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SalarySanaria is a biotechnology company at the cutting edge of vaccine innovation. We are passionate about our goal to eradicate malaria. Sanaria employees are exceptional scientifically, mission-driven, and play a variety of roles in research, product development, manufacturing, clinical trials, and support of these endeavors. We celebrate our diversity and offer a strong benefits package including company paid life and disability insurance, health plans with employee and dependent subsidy, and 401k plan with company match.
We are looking for a highly organized and motivated individual to fill the role of Document Control Specialist with excellent customer service skills and acute attention to detail. This individual must be capable of working in a fast-paced environment and able to make decisions based on policy and procedures. Prior experience with implementing electronic document management systems (EDMS) is a plus. This position reports to the Quality Assurance Manager.
We are currently seeking a highly organized and motivated Document Control Specialist with relevant experience in pharmaceutical manufacturing environment. The successful candidate must have excellent customer service skills with high attention to detail. The Document Control Specialist must be capable of working in a fast-paced environment and able to make decisions based on policy and procedures. Prior experience with implementing electronic document management systems (EDMS) is a plus.
This position reports to the Quality Assurance manager.
Primary Responsibilities
- Enforce GMP requirements and QA directives with regard to documentation, including document formatting and Good Documentation Practices (GDP).
- Manage electronic and or paper document change requests (DCRs).
- Administer document change control including tracking, controlling, and managing manufacturing documentation and review
- Administer control document issuances by making copies of master documents, stamping, distributing and tracking copies.
- Maintain files for manufacturing, QC, QA, Safety, Materials Control and Equipment/Facilities
- Assign and track final product and intermediate Lot numbers
- Issue and track labels
- Provide excellent customer service to internal customers, ensuring adherence to department timelines.
- Provide support during regulatory and other inspections; maintain a state of inspection readiness.
- Assist Regulatory in Document submission.
- Write and or revise Document Control procedures and policies.
- File documents in the QA archive; retrieve documents from the archive upon request.
Secondary Responsibilities (as needed)
· Review equipment and room logs
· Review Materials Control documentation
· Review other GMP documents
Required Qualifications and Experience
- Minimum of an AS degree, preferably in a scientific field.
- AS degree: 2+ years of GMP documentation experience.
- BS degree: 0+ years of GMP documentation experience.
- Excellent writing skills and editing, formatting, and organization skills.
- Excellent attention to detail and customer service attitude.
- Familiarity and aptitude with Microsoft word and Microsoft Excel and Adobe PDF.
Preferred Qualifications and Experience
- Familiarity with ICH and FDA guidelines, GMP regulations, and quality compliance requirements preferred.
- Experience with EDMS
Please send cover letter, resume and required pay rate to careers(at)sanaria.com, subject line “Document Control Specialist.” For more information, please visit our website, sanaria.com. Sanaria Inc. is an Equal Opportunity Employer.'
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Work Location:
- One location
Work Remotely
- No
Job Type: Full-time
Pay: $48,000.00 - $50,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Schedule:
- Monday to Friday
Education:
- Bachelor's (Preferred)
Experience:
- Document Management: 1 year (Preferred)
Work Location: In person
