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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing change control documentation and workflows within electronic Quality Management Systems, ensuring compliance with cGMP standards. Proficient in data entry, report generation, and effective communication across departments.
Highest-signal resume keywords
Change Control ManagementElectronic Quality Management System (eQMS)CGMP ComplianceData Entry and ReportingDocument Management System
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Data EntryChange Control DocumentationCGMP ComplianceReport GenerationWorkflow ManagementAnalytical SkillsTroubleshootingProblem-SolvingRecord KeepingProject Management
Soft Skills
Attention to DetailStrong Work EthicOrganizational SkillsInterpersonal SkillsCommunication Skills
Tools & Technologies
Microsoft ExcelMicrosoft OutlookMicrosoft WordAccess Change Request DatabaseVeevaDocument Management System (DMS)EQMS
Industry Keywords
CGMPQuality ManagementChange ControlDocument ManagementKey Performance Indicators (KPI)
About the role
Key responsibilities & impact- Manage daily data entry and change control documentation in the Access Change Request Database
- Review and manage workflows for change control records in the electronic Quality Management System (Veeva)
- Review change control and associated requirements documentation for accuracy, completeness, cGMP compliance, and applicable standards
- Generate scheduled reports on open and closed change requests and document issuance
- Follow up on open requirements and change control status
- Send change control notifications to other Grifols sites as required
- Issue tag-outs for equipment and facilities as required by change control
- Generate reports and data for Key Performance Indicator reporting
- Process and maintain documents in the Document Management System, including review, approval, issuance, and effective workflows
- Assist with projects related to document management systems and change control
- Use Microsoft Excel, eQMS, and Access for tracking, trending, and data entry
- Communicate with multiple departments to provide customer service
Requirements
What you’ll need- Bachelor's degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience
- Related cGMP industry experience is desirable
- Experience working with eQMS highly desirable
- Ability to keep neat, accurate and complete records and logs
- Proactive, results oriented, with strong attention to detail
- Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team
- Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced critical work environment
- Strong organizational, analytical, troubleshooting and problem-solving skills
- Ability to analyze details and perform structured decision-making daily
- Excellent verbal and written communication
- Must be able to read, write, and speak English
- Strong interpersonal skills and ability to interact professionally with all levels of personnel
- Good computer skills, including Microsoft Outlook, Word, Excel, Access, and eQMS
- Ability to work in office, laboratory/manufacturing, or warehouse environments
- Ability to use required personal protective equipment
- Ability to lift and carry up to 35 lbs
- Near vision correctable to specified standards and color perception/discrimination
- Ability to follow written or oral instructions and procedures
Benefits
Comp & perks- Up to 5% of the company bonus pool
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- PTO
- Paid holidays
- Up to 5% 401(K) match
- Tuition reimbursement
- Professional growth and career progression opportunities