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The purpose of this position is to support the site’s overall document control and VEEVA QDocs systems. The position monitors and sets VEEVA document effective dates, reports and monitors periodic reviews and obsoletions, issues manufacturing batch records and packaging procedures according to schedule, oversees controlled documents in the site document management system (VEEVA), maintains document control Mastertrac filing system, issues protocols and Logbooks, and ensures compliance with site requirements for documentation, archival and retention. The position supports the L&D training program and assists during inspections.
Basic Minimum (Required) Qualifications:
- High School Diploma/GED with relevant work experience or an Associate’s degree.
- Work experience in USDA or regulated animal health industry is beneficial.
- Good written communication skills, including attention to detail, ability to follow written procedures, SOPs, specifications and other documents, and ability to perform basic mathematical calculations are required.
- Demonstrated high ethical and professional standards with all business contacts in order to maintain Elanco’s excellent reputation in the community.
- Requires basic knowledge and skill related to own work, may have some specialization.
- Recognizes and solves typical problems that can occur in own work unit.
- Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
1.) Batch Record Issuance:
- Prepares batch record documentation and performs review for compliance to Good Documentation Practices and against established SOPs/standards.
- Issued Records are available according to production schedule and approved cycle time based on as needed requests
- Documentation conforms to all applicable regulations (cGMP, 9 CFR) requirements prior to product release.
2). Batch Record Reviews:
- Reviews batch records for compliance and good documentation practices
- Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP.
- No product release delays, recalls or regulatory citations occur due to incorrect issued documentation. Holds quality and reliability as high standards of production and service for own work.
- Errors are tracked and handled in a timely manner to avoid release delays.
3.) Document Control:
- Ensure Document Control systems are established and implemented to facilitate system of filing and retrieval of documentation.
- Establishes system and procedures to ensure consistency in reporting practices.
- Provides training on good documentation practices for the site
- Ensures SOPs, Records are compliant with the site procedure on SOPs
- Processes records through site Electronic Document Management System
- Ensure documents are stored, traceable and retrievable through the Mastertrac system and retention policy.
- Maintains document control area in a state of control, compliance and inspection ready.
4). Change Control:
- Completes change control action items as assigned.
- Ensure Quality Record Issuance Holds are implemented per the change control impact assessment
- Action items are completed by due dates. No delays in change control closure due to incomplete action items.
- System controls are implemented to prevent release of material with an open change control.
- Participates on CAPA teams in area of expertise as needed
- Ensure Batch Record Holds are implemented per the deviation impact assessment
- Initiates deviations in Quality electronic systems when non-conformances are detected.
- QA approvals are performed in a timely manner.
- CAPAs are accurately completed by target due dates.
- System controls are implemented to prevent release of material with an open deviation or observation.
- Actively participates on project teams as assigned by Manager
- Coordinates and leads projects with supervision.
- Contributes to idea generation and solution development/process improvement. Provides data to support implementation and suggests new ways to apply existing knowledge. Completes assigned tasks by due dates.
- Projects are completed by due dates. Displays respect and appreciation for individual differences; values contributions of others
- Provides Learning and Development system admin support coverage for the site.
- Supports L&D projects
- Maintenance of L&D systems and processes
- Identifies and resolves potential L&D gaps
- Coordinates with site department leaders to ensure curricula is suitable for the roles
- Completes change requests for L&D material revisions and curricula changes
- Provides guidance in training method selection and evaluation of effectiveness methods
- Completes all assigned training by target due dates as assigned.
- Completes on the job training for each assigned job task.
- Cross trains on other job tasks within department.
- Assists with training other individuals within the department on specific tasks.
- Provides customer support and maintains compliance with approved L&D processes
- Routinely monitors assignments in SuccessFactors to assure training is up to date. Curriculum reviews completed by the periodic review dates.
- Willingly learns new tasks to support others during times of high batch volumes/workloads/staff shortages in Doc Control.
- Performs training with other individuals in a timely manner and according to written procedures to support team.
- Participates in internal audits and record requests as assigned by management.
- Audit preparation for regulatory agency audits/customer inspections and participation through demonstration of job tasks during inspections may be required as needed.
- Some lifting up to 10 lbs. may be required for handling of archive boxes.
- Primary work hours are first shift however, some overtime may be required due as business requirements change.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status