Document Control Specialist-II

ID# DCPA31140

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

The Document Control Specialist is responsible for tactical activities related to all aspects of document control (creation, revision, approval, distribution, obsolescence and retention) providing daily support to the Lancaster Site consistent with the supply chains’ goals while meeting the compliance goals of QA. 

Quality Process Focus: 

  • Administrator for the EDM System for Document Control. 
  • Administrator for site for Document Retention assuring the site maintains documentation as per corporate and regulatory requirements. 
  • Provide EDM training and access. 
  • Initial review and comment on GMP Documentation (SOP’s, MBR’s, etc. 
  • Responsible for completion of data required for monthly APRs. 

Compliance Focus:

  • Support efforts for tactical compliance improvements. 
  • Prepare management reports as needed. 
  • Actively participate at Process Review Team Meetings. 
  • Team with process management to support process improvement and ongoing support in meeting metrics goals. 
  • Responsible for achieving day-to-day process outcomes for the entire process. 
  • Identify Compliance gaps and provide resolution proposals 

Customer and Performance Improvement Focus (5%) 

  • Assure customer service to the Process to promote achievement of process goals. 
  • Identify opportunities to streamline and/or simplify existing systems. 

Education: 

  • 3-5 years Pharmaceutical GMP Experience in a Compliance position. 
  • B.S. or B.A. College Degree (Science or Technical Degree preferred). 
  • Demonstrate sustained performance through results (minimum of 2 years). 

Experience: 

  • Demonstrated leadership- possesses the ability to lead a team. 
  • Strong decision-making ability. 
  • Asks the right questions to form appropriate decisions. 
  • Gathers all relevant information and elevates issues appropriately. 
  • Keen attention to detail. 
  • Expertise in handling multiple priorities. 
  • Demonstrated ability to maintain positive working relationships with others. 
  • Must demonstrate firm conviction on regulatory boundaries, in the face of challenges and pressures. 
  • Strong communication and organizational skills. 
  • Strong appreciation for quality in the process and the product. 
  • Minimum 3 years Pharmaceutical Manufacturing or Quality Experience. 
  • Affinity for and Knowledge of Computer Systems. 
  • Ability to work independently on routine tasks. 
  • Awareness of Quality functions and business areas. 
  • Basic negotiation, influencing, and conflict management skills. 
  • Strong Organizational Skills / Communication Skills. 

Knowledge/Skillsets 

  • SOP author. 
  • High performer / SME. 
  • Proficient in SAP, Word, Excel, EDM, and Outlook. 
  • Pharmaceutical Manufacturing or Quality Experience. 
  • Computer Systems Validation Experience. 

Position Details:

Consumer Product

Business

Start Date: 
9-7-2014
End Date: 
3-31-2015

LANCASTER, PA

Full Time

40

DCPA31140

No

No