Job Location : Durham,NC, USA
Job Title: Production Document Control Area Specialist I
Duration: 6 Month Contract (High Possibility of extension)
Location: Durham, NC
Client : Novo Nordisk
Pay : $22/hr on w2 without benefits
Job Summary:
Provide routine support & troubleshooting for the batch & documentation review process in production operations. Ensure that batch documentation as well as SOPs & other standardized documentation from production is in accordance with internal & external requirements. Follow-up & trouble-shoot challenges & clarifications needed to ensure high-quality batch review. Be part of continuously improving batch review system to support production plans. Meet or exceed customer, business & regulatory requirements.
ESSENTIAL FUNCTIONS
• Continuous improvement of Manufacturing processes.
• Issuance & tracking of all batch related documentation.
• Establishment & driver of batch review & documentation processes in bulk.
• APR document support.
• SOP owner review.
• Ensure real time review to include BPR, logbooks, etc.
• Ensure site compliance with cGMPs, ISO standards corporate & local SOPs.
• Review & timely approval of executed batch production records (BPRs) ensuring accurateness & compliance with approved procedures & regulations.
• Coach OFP Bulk employees regarding quality related activities.
• Ability to adjust to changing priorities.
• Generate ideas for improvement within area & support implementation.
• Ability to work in a team.
• Support minor deviations.
• Other accountabilities, as assigned.
QUALIFICATIONS
• Associate's degree in technology, Science, or Pharma or equivalent industrial, military, or vocational training combined with experience required.
• Minimum of three (3) years of experience operating in a GMP regulated environment preferred.
• Minimum of three (3) years of word processing & electronic document distribution required.
• Experience with documentation in the pharmaceutical industry, like batch reports, SOPs, etc. Knowledge about requirements/expectations of regulatory authorities e.g., FDA required.
• Experience with IT systems, e.g., Adobe, Excel, SAP, material control systems, etc required.
• Proficient with problem solving techniques required.
• Required to demonstrate strong attention to detail, proofreading & strong computer skills with a willingness to learn new IT systems required.
• Excellent written & oral communication skills required.
• Proven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing a plus.