Immediate opportunity for an experienced Document Control / Records Management Specialist to join a well-funded clinical stage biotech startup located in Atlanta, GA. Apply Today!
Position Overview : As a Document / Records Management Specialist, you will develop and maintain document and record control systems in the FDA regulated biologics, pharmaceutical, and medical device industries.
Looking for an experienced candidate who can also contribute input into different electronic systems to transition from paper system.
Essential Duties and Responsibilities :
- Maintain document control systems (electronic / paper) compliant with regulatory / standards requirements and company procedures / systems.
- Maintain external documents compliant with regulatory / standards requirements and company procedures / systems.
- Maintain record control systems (electronic / paper) compliant with regulatory requirements and company procedures.
- Maintain specimen, and reference and retention sample control systems compliant with regulatory requirements and company procedures / systems.
- Maintain training matrices (electronic / paper) compliant with regulatory / standards requirements and company procedures.
- Provide expertise and input to other functional areas including but not limited to Engineering, Research, Development, Quality, Production regarding documents, specimens / samples, and good data recording practices (ALCOA+).
- Creates, reviews, and approves documents procedures, protocols, reports, etc.
- Quality assurance review and disposition of products.
- Represents Quality on interdepartmental project teams.
- Conduct company-wide training (e.g., documents, records, and specimens / samples).
- Conducts internal and supplier audits.
- Ensures in a positive way compliance with regulatory / standards requirements and company procedures.
- Participates in professional organizations to ensure that state-of-the-art industry regulatory / standards requirements are communicated within the company and implemented in an efficient, timely, and accurate manner.
- Manages projects as assigned.
- Maintain and present quality indicator metrics.
- Has some independence for unreviewed action or decision.
- Effectively manage time and multiple task assignments.
- Other duties as assigned by management.
Qualifications :
- Bachelor's degree (BA / BS) in relevant field.
- Five (5) or more years’ experience with document control / records management in a FDA regulated industry.
- Working knowledge and experience with GMP or QSR / ISO 13485 or ISO 9001
- Working knowledge and experience with paper- / electronic-based document management systems.
- Expert : MS Word, MS Excel, MS Power Point, Adobe and / or Adobe Creative Suite.
- Design / create product labels, product labeling (e.g., IFU, product inserts), audio-visual trainings
- Excellent communication skills (oral, written, and presentation) and understanding of how to present information to various audience levels.
- Detail oriented with excellent organizational skills.
- Ability to work independently as well as in a team environment.
- Ability to work independently and collaboratively in a fast-paced environment
Preferred Skills / Experience :
- GLP, GCP, and related ISO and ICH
- Experience working with engineering drawings using SolidWorks or AutoCAD
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