Pharmaceutical Documentation Specialist

Job Description:

Type: 6 month Contract to Perm position

Schedule: Monday - Thursday 6:00 AM - 4:30 PM

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 in accordance with Novo Nordisk Way.

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.

PHYSICAL REQUIREMENTS

Ability to work in an open office environment with the possibility of frequent distraction.

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.

$ 20.00/hr

HV23