Fully Onsite - occasional flexibility to WFH (1-2 days per week after 6 months) - standard working hours 8 AM - 5 PM
Ideal candidate: B.S. 2+ YOE would be ideal, previous Veeva experience, and prior deviation and CAPA experience.
What you will do
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), protocols, technical reports, and training material in a GMP regulated environment that supports the manufacturing process.
Develop, review, and update technical content including but not limited to standard operating procedures, work instructions, risk assessments, protocols & reports for manufacturing team.
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 Manufacturing to support change controls, deviations & troubleshooting investigations with provision from relevant SMEs.
Generate, own, and provide subject matter expertise to Quality System records as minor deviations, CAPA and change control records.
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.
Basic Qualifications:
Master's Degree in Science and/or Engineering.
Or
Bachelor's Degree in Science and/or Engineering and 2 years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.
Or
Associate s Degree in Science and/or Engineering and 5 years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.
Or
High School Diploma / GED and 8 years in Manufacturing, Packaging or Quality experience in pharmaceutical, medical device or biotechnology companies.
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 demonstrated 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.
Dynamic 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 problem solver with strong troubleshooting and problem-solving skills.
Pro-active with the ability to prioritize work to meet benchmarks
Good documentation and communication