Document Control Specialist
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Job Detail
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Job Description
Sanaria is a rapidly growing, diverse, inclusive, multi-cultural, 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 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 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
We offer a competitive salary and benefits package. To apply, please submit your letter of interest and resume to careers(at)sanaria.com . Subject Line “Document Control Specialist”. Sanaria is an Equal Opportunity Employer.