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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates proficiency in Good Documentation Practices and compliance with cGMP standards while effectively managing batch documentation and data accuracy. Capable of utilizing AS400 and SAP for tracking and reporting, alongside strong analytical and mathematical skills.
Highest-signal resume keywords
Good Documentation PracticesCGMP ComplianceAS400 ProficiencySAP ProficiencyAnalytical Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Good Documentation PracticesCGMP ComplianceAnalytical SkillsBasic MathematicsBatch ReviewData AccuracyFinal ReconciliationInvestigationsTrend TrackingReport Maintenance
Soft Skills
Effective CommunicationCollaborative TeamworkAdaptabilityAttention to DetailProblem-Solving
Tools & Technologies
AS400SAPMicrosoft OfficeExcelWordPowerPointSharePointVeeva
Industry Keywords
ManufacturingBatch DocumentationSOPsComplianceQuality AssuranceSafety RulesPowder ExposureChemical Exposure
About the role
Key responsibilities & impact- Review the accuracy and completeness of documentation pertaining to manufacturing batches following Good Documentation Practices
- Adhere to SOPs and current cGMPs while assuring product quality and quantity
- Establish priorities aligned with daily schedules
- Check in-process data, including weights, seams, and other information, against established specifications
- Check and complete final reconciliations for compliance
- Assure the presence and disposition of investigations, deviation reports, and rework documents when required
- Initiate and participate in investigations when documents or data are missing
- Bring Good Documentation Practice issues to the attention of the Lead or Supervisor
- Update batch status in AS400 and SAP
- Comply with company policies and procedures and maintain regular work attendance
- Follow safety rules, SOPs, and cGMP guidelines
- Run and maintain reports
- Track and trend key indicators related to batch review
- Perform other duties as assigned
Requirements
What you’ll need- Associate's or bachelor's degree preferred
- Proficient computer skills, including Microsoft Office
- Proficient basic mathematical and analytical skills
- Computer literacy and proficiency in math, basic statistics, office, and technical applications
- Proficiency with AS400, SharePoint, Excel, Word, PowerPoint, Veeva, and SAP
- Familiarity with GMP and Good Documentation Practices
- Good English verbal and written skills
- Ability to remain effective during major changes in work tasks or the work environment and adjust to new structures, processes, requirements, or cultures
- Ability to work collaboratively within teams
- Work environment may include exposure to powders, chemicals, and allergens, including peanuts, tree nuts, milk, dairy, eggs, wheat, gluten, soy, fish, sesame, and shellfish
- This position is not eligible for Visa Sponsorship
Benefits
Comp & perks- Performance-based incentives
- 401k with company match
- Healthcare coverage
- Competitive total rewards package
- Benefits supporting physical, financial, and emotional wellbeing
- Dynamic career paths
- Robust development opportunities
- Opportunities to learn from talented colleagues around the globe