Description:
Note:

• Onsite - New Albany, OH

Ideal Candidate: 

• Educational Background in Science and/or Engineering. 
• Experience working in GMP pharma and/or biotechnology industry.
• Exposure to KNEAT CDOCs highly desired. 
• Can communicate with edit documentation, understands formatting aligned with corporates policies and templates. 
• Interested in seeing sample writings if they can be provided.

    
WHAT YOU WILL DO

• Let’s do this. Let’s change the world! In this role you will support the manufacturing team and provide technical expertise to regularly draft and revise documents such as Standard Operating Procedures (SOP'S), Work Instructions (WI), protocols, technical reports, and training material in a GMP regulated environment that supports the manufacturing process.
• This role will also lead and own quality records such as deviations, CAPAs, Change Controls, and Quality Risk Management and provide expertise in Quality Management System (QMS).

Responsibilities may include, but are not limited to:

• Develop, review, and update technical content including but not limited to SOPs, WIs, risk assessments, protocols & reports for manufacturing team.
• Generate, own, and provide subject matter expertise to Quality System records as minor/major deviations, CAPA and change control records.
• Provide technical and clerical support to the manufacturing team in the preparation of documentation, collation of data and tracking of technical documents.
• Liaise with manufacturing team and other cross functional departments regarding documentation changes in an effective and timely manner.
• Collaborate with multiple departments to support new/revise training documentation for manufacturing staff.
• Support process owners and participate in continuous process improvement and / or troubleshooting projects.
• Support manufacturing team in reducing document turnaround times.
• Ensure documentation related actions are completed on time and current schedule is maintained, accurate, and up to date.
• Develop protocols for execution in Manufacturing to support change controls, deviations & troubleshooting investigations with provision from relevant SMEs.
• Track pending activities required to support change control implementations.
• Liaise with Quality Assurance to ensure that GMP standards are maintained in line with current operating systems.
• Share knowledge with members of the manufacturing team.

WHAT WE EXPECT OF YOU

• We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

Preferred Qualifications:

• Educational Background in Science and/or Engineering.
• Experience working in GMP pharma and/or biotechnology industry.
• Experience in a Good Manufacturing Practices (GMP) environment and solid background in technical writing.
• Experience with device assembly and packaging of final product.
• Ability to translate highly technical information into easily understandable information for manufacturing operators.
• Creative skills and usage of photographs, drawings, diagrams, animation, and charts that increase users’ understanding.
• Experience supporting deviations, investigations, CAPA’s and change controls.
• A fact-based thinker with strong troubleshooting and problem-solving skills.
• Pro-active, result driven, and ability to prioritize work to meet deadlines.
• Good documentation and communication skills.

Basic Qualifications

• Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience.

Top 3 Must Have Skill Sets:    

• Excellent technical writing skills.
• Ability to read and understand technical documents.
• Excellent communication skills.

PAY RATE : $38/Hr on W2.

"This posting is for Contingent Worker, not an FTE"