Document Control Assistant

Purpose: PURPOSE & SCOPE This position is responsible for processing controlled documents for revision, approval and issuance as needed and assisting with the department?s general administrative activities.

The Document Control Assistant is responsible for performing, monitoring and maintaining change control and records processing tasks and other responsibilities for the Document Control Department.

The position works under general supervision. The position responds to multiple internal contacts at all levels in the organization in the work of document processing and records archiving and recovery, thus demonstrates strong customer response and focus.


ESSENTIAL RESPONSIBILITIES

Document Change Control

1. Learn and follow the department?s established procedures for controlled document change control work activities. These include procedures specific to document processing, offsite storage, database entries, and retention schedules and procedures.
2. Document Change Control. Process, per change control procedures, documents identified as controlled document types generated under current Good Manufacturing Practices (cGMP), good Laboratory Practices (GLP), and Good Clinical Practices (GCP). These documents include (but are not limited to): Standard Operating Procedures, Master Batch Records, Specifications, Material Safety Data Sheet and BioAnalytical Research and Development Methods.
a. Maintain databases and spreadsheets used in tracking documentation routing, history and reporting.
b.For matting, typing and editing SOPs, Specifications and all other controlled documents.
. Document revision and approval process
d. Approved document revision update process

Document/Records Processing

1. Learn and follow the department?s established records procedures for the safe handling of controlled documents and records for all work activities. These include procedures specific to notebooks, offsite storage, database entries, and retention schedules and procedures.
2. Notebooks. Respond to requests from for new scientific notebooks. Also respond to scientist for requests to retrieve notebooks from offsite storage. Conduct quality control checks of each notebook upon receipt, to ensure standard guidelines have been followed, prior to granting release.
3. Offsite Storage. Package designated records and document information in readiness for pick-up and safe delivery to offsite storage. Contact offsite vendor regarding retrieval and return of items.
4. Data Entry. Maintain records information within the records databases and related to the movement of records, on-site and off-site storage of records, index of related records, etc. within the fireproof records room.
5. Retention Schedules & Procedures. Ensure that records and documents are retained and sent off site for storage per the established Records and Retention Schedule procedure.
6. Records Room Database. Enter new records into records room database, as needed.

Controlled Document Filing and Scanning
1. Follow the established procedures for the filing of controlled documents and records.
2.File hard copies of all documents into the filing system, daily.
3.File hard copies of all records into the filing system, daily.
4.Scan master copies and supporting documents on an as needed basis.
5.Scan master copies and supporting documents into ZDMS database daily.
6. Organize and update Records Storage and Retrieval procedure on an as needed basis.
7. Order paper supplies, upon request or as needed.
8.ZDMS Database. Enter specific document data as required. Participate in the ZDMS User Group Team that meets on an on-call basis.

General Group Support
1. At the direction of and training by the Manager, Document Control, assist with processing change control review meetings.
2. Proofread (audit documents) for accuracy and maintain deadlines for the completion of work.
3. Actively participate in the regular weekly department meetings.
4. Participate in special projects as assigned.

SKILLS, EDUCATION & EXPERIENCE
1. BA/BS Degree preferred.
2.1-2 years of cGMP change control experience.
3. Basic knowledge of MS Word, Outlook and Excel.
4. Aptitude for learning how to run simple queries in Excel databases.
5. Demonstration of strong detail orientation, organizational skills and the ability to work independently and multi-task.
6. Competencies: Adaptability. Accountability. Teamwork, Communications, Initiative.
7. Able to lift 25 lbs consistently and 50 lbs occasionally.

Classification:
Full-Time

Compensation:
$16.00 - $21.00 Hour

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries is an equal opportunity employer.

Required Qualifications:
Skills Requirements:
cGMP, Excel Queries and Databases, GLP, GCPContact Information
Contact:Ehrler,Emily S