Document Control Specialist - Submissions, EDMS (code:JRM)

Data Factory Specialist
Collegeville, PA 19426


*******

With this position, I'm looking for a Pharmaceutical document control background, especially working with Documentum (or other EDMS).  I know the job description is detailed, but this is the focus when reviewing candidates.  I'm looking for candidates who are interested in both 1st shift openings and 2nd shift openings (3-11pm)

*******

Job Description:
This position will be responsible for all tasks associated with Global Product Conformance (GPC) Regional Hub Data Factory operations including data receipt, loading into Electronic Document Management System (EDMS), linking in Product Dossier Manager (PDM), verification of linked/loaded data, and translation activities. Incumbent will perform the necessary quality checks to ensure that Data Factory operations are in accordance with GPC Guidelines.

Key Accountabilities:
• Performs the data receipt process & notifies senders of discrepancies
* Executes Data Factory processes in accordance with GPC Guidelines
* Pays strict attention to detail to ensure documentation appears accurate and process steps followed
* Scan documents using technology and equipment provided
* Confirms that product properties are available in Global Product Registrations (GPR) and PDM; initiates update process when appropriate
* Import documents into EDMS; promotes documents to the Final cabinet after quality check
* Links documents to PDM
* Conducts appropriate quality checks to ensure completeness and accuracy of scans, EDMS importation and PDM linking
* Acts as a contact/liaison with Affiliate or Plant personnel regarding quality check and verification activities
* Acts as contact/liaison with translation vendor, as needed
* Assists in the tracking of Data Factory operations
* Provides updates to Data Factory Coordinator on progress and issues
* Additional tasks to support GPC as designated by the GPC Regional Data Factory Coordinator, Regional Hub Lead and GPC Program Management Office (PMO)

Job Specification:

Job Knowledge / Technical Skills / Experience
• A minimum of a degree level or equivalent qualifications
• Experience in administrative work
• Strong skills in English language (written and oral)
• Understanding of regulatory submission processes and Common Technical Document (CTD) structure
• Strong computer skills
• Experience using Excel and Adobe Acrobat
• Experience with EDMS, preferred
• Understanding of Good Manufacturing Practices (GMP) guidelines
Interpersonal Skills
• Attention to detail, right-first-time mentality
• Ability to operate effectively in environment with routine tasks
• Good organization and time management/task management
• Strong desire to achieve optimal results
• Ability to adapt and be flexible; multi-task
• Good decision making ability

* Significant interaction with Data Factory members, Regional Data Factory Coordinator and Regional Hub Lead
* Interaction with different departments within the Plant, Affiliate, and Regional Hub including Regulatory Affairs & Regulatory Conformance
* External interaction with the translation vendor

Behavior Characteristics:
.
 

  Required / Desired Skills 
 

Skill  Required / Desired 
Regulatory submissions experience  Nice to have  2  Years  Competent 
CTD proficient  Required  2  Years  Competent 
Documentum experience  Highly desired  2  Years  Competent 
Ability to master new skills quickly  Required  2  Years  Competent

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs      > Document Control      > Other Pharmaceutical
Location:	Collegeville, PA
County:	Montgomery County
ZIP Code:	19426
Pay Rate:	Open
Job Terms:	full time
Company:	APEX Systems, Inc.
Phone:	email only
Fax:	email only