A typical day will consist of creating/revising production, QC, dispensing, and packaging procedures. Creating/revising Material Specifications, label templates, and label contents.  Creating/routing DIR/ERs for approval, monitering the status of the DIR/ER.  Assist with WI creation/update in Veeva. Filing and archiving batch record when needed etc.

$33-$38

How You'll Make An Impact:

• Contribute to timely product release to meet the business goals to deliver product to customers on time by completing assigned tasks on time.
• Communicating technical issues and concerns promptly to escalate/establish root cause to move the process forward.
• Identify areas for improvement in documentation processes/procedures and execute projects to implement changes.

Job Duties/Qualifications:

• Collaborates with the Quality department to manage and track Change Requests.
• Creates or revises new materials and new material specifications.
• Creates or Revises production procedure/QC procedures.
• Reviews documents for format, accuracy and compliance with existing procedures, providing feedback on content as appropriate in collaboration with area experts.
• Creates and revises label specifications in Label Content Records (LCRs), templates and processes manufacturing updates through DIR workflow.
• Participates in CR Meetings and revising documents and ERP data.
• Maintains the Document Storage Area for all controlled documents.
• Conduct manual create Recipe and BOM setup on SAP
• Troubleshoot for label printing issues as needed.
• Create department SOPs, Work Instruction, Packaging/dispensing procedures if needed.
• Perform required Product Lifecycle Management (PLM) System changes through document routing approval, Tier 2, and Engineering Records (ER) release as needed.
• Filling/archiving product batch records
• Evaluate change requests/logging the requests
• Update/create KMI

What You Bring:

• Bachelor’s degree or equivalent in a related field.
• At least 2-3 years documentation related experience.
• Strong communication MS Office especiallly strong on word and excel.
• Strong customer orientation and focus.
• Familiarity with SAP or similar ERP systems a plus.
• Understanding of ISO 13487, FDA regulations. GMP and GLP
• Know PLM, Veeva, or EtQ is a plus
• A willingness to learn new processes, embrace new ideas and challenges is extremely desirable.
• The ability to flex and adapt to unexpected changes in flexable schedule is extremely desirable.
• The ability to work amongst a small and diverse team and communicate effectively is highly desired due to this role being very collaborative