Document Control Specialist - Compunnel : Job Details

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.