Production Document Control Area Specialist

Role Summary

Provide routine support and troubleshooting for the batch and documentation review process in production operations. Ensure that batch documentation as well as SOPs and other standardized documentation from production is maintained in accordance with internal and external requirements. Follow up on and troubleshoot challenges/clarifications needed to ensure high-quality batch review. Participate in the continuous improvement of the batch review system to support production plans. Meet or exceed customer, business and regulatory requirements in accordance with Novo Nordisk Way.

Responsibilities

• Participate in the continuously improve of Purification, Recovery & Fermentation supporting documentation processes
• Execute batch review and documentation processes in operations
• Support Annual Process Review (APR) documentation and SOP reviews
• Ensure real time review to include BPR, logbooks, etc.
• Ensure site compliance with cGMPs, ISO standards corporate and local SOPs
• Review and approve, in a timely manner, executed batch production records (BPRs) ensuring accurateness and compliance with approved procedures and regulations
• Generate ideas for improvement within area and support implementation of ideas
• Ability to work in a team for batch reviews
• Support minor deviations
• Follow all safety and environmental requirements in the performance of duties
• Other accountabilities as assigned

Qualifications

• Required: Associate‚Äôs Degree in Technology, Life Science, Pharma or a relevant field of study from an accredited university
• Required: High School Diploma or equivalent with five (5) years of experience operating in a GMP regulated environment
• Preferred: Bachelor‚Äôs Degree in Technology, Life Science, Pharma or a relevant field of study from an accredited university
• Required: Minimum one (1) year of experience operating in a GMP regulated environment
• Required: Minimum two (2) years of word processing and electronic document distribution
• Required: Experience with documentation in the pharmaceutical industry, like batch reports, SOPs, etc.
• Required: Demonstrated knowledge of requirements/expectations of regulatory authorities (e.g., FDA)
• Required: Experience with IT systems, e.g. Adobe, Excel, SAP, material control systems
• Required: Proficient with problem solving techniques
• Required: Demonstrated experience with strong attention to detail, proofreading and strong computer skills with a willingness to learn new IT systems
• Required: Excellent written and oral communication skills
• Preferred: Proven ability to establish and maintain networks and facilitate processes that encourage cross-organizational knowledge sharing

Skills

• Problem solving and analytical thinking
• Attention to detail and proofreading
• Strong written and verbal communication
• Cross-functional collaboration and teamwork
• Adaptability to work with IT systems and new tools

Education

• Associate‚Äôs Degree in Technology, Life Science, Pharma or a relevant field of study (required)
• Bachelor‚Äôs Degree in Technology, Life Science, Pharma or a relevant field of study (preferred)

Additional Requirements

• Travel up to 10% of the time (may vary by role)