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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