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 maerlaria. 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 currently seeking Document Control Specialist with 2-5 years of experience. This position reports to the Director, Quality Assurance, and works closely with the Sr. Director, Quality and QA Specialists.
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.
Essential Duties and Responsibilities
Enforce GMP requirements and QA policies 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
Review equipment logs
Review Materials Control documentation
Provide excellent customer service to internal customers, ensuring adherence to department timelines.
Write and or revise Document Control procedures and policies.
File documents in the QA archive; retrieve documents from the archive upon request.
Provide support during regulatory and other inspections; maintain a state of inspection readiness.
Minimum of a Bachelor’s degree, preferably in Biochemistry, Biology, Chemistry, or other scientific field and 2+ years of GMP documentation experience.
Experience with EDMS. Experience with Novatek software a plus.
Familiarity with ICH and FDA guidelines, GMP regulations, and quality compliance requirements preferred.
Excellent writing skills and editing, formatting, and organization skills.
Excellent attention to detail and customer service attitude.
Please send cover letter, resume and required pay rate to careers(at)sanaria.com, subject line “Document Control Specialist.” For more information, please visit www(dot)sanaria.com. Sanaria Inc. is an equal opportunity employer.
Job Type : Full-Time
Education Level : Bachelors Degree, Masters
Experience Level : Entry Level, Mid to Senior Level