Karen Grant
Aurora, CO,CO
Summary
Proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth.
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
15
15
years of professional experience
Work History
Document Controller
Teva Pharmaceuticals
02.2009 - 09.2022
- Utilized advanced software tools to improve overall document control processes, leading to increased productivity levels within the team.
- Checked accuracy and completeness of documents to identify deficiencies and recommend corrective actions.
- Monitored due dates and deadlines and worked to submit all documents on time or early.
- Allocated unique document numbers to internal documents and incoming external documents and tracked in database.
- Reduced errors in documentation by maintaining consistent formatting and proofreading for accuracy.
- Provided support for document controls and worked with contract documents.
- Assisted in the preparation of regular document control reports for senior management, providing valuable insights into project progress and areas requiring attention.
- Maintained strict compliance with industry regulations governing document retention periods, archiving obsolete materials promptly and securely when required.
- Carefully reviewed all documents and reports for completeness and accuracy.
- Supported quality assurance efforts by conducting thorough audits of existing documentation and making necessary revisions as needed.
- Maintained document archive and file server of approved documents and drawings to provide easy traceability and retrievability.
- Demonstrated adaptability by quickly learning new software platforms and adjusting processes as needed to accommodate evolving project requirements or client preferences.
- Maintained accurate records of all project-related documents, facilitating quick retrieval when needed.
- Contributed to ongoing process improvements by participating in regular meetings with key stakeholders to discuss challenges, successes, and opportunities related to document control practices.
- Optimized workflow efficiency by proactively identifying bottlenecks in the document management process and proposing solutions for improvement.
- Scanned, filed and transmitted various documents and adhered to digital filing procedures.
- Converted documents from one application to another.
- Managed regulatory requirements and audit support needs by completing and submitting accurate paperwork.
- Coordinated document exchange between departments, contractors, suppliers, and customers.
- Maintained legally compliant, highly secure and user-friendly content to facilitate smooth use by internal and external stakeholders.
Regulatory Affairs ECTD Submissions
Teva Pharmaceuticals
05.2007 - 02.2009
- The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and ia(CDER) and Center for Biologics Evaluation and Research (CBER).
- Assisted Regulatory Affairs Specialists in research and compilation of drug dosage, manufacturing practices and building eCTDs for submission to the FDA.
- Demonstrated strong organizational and time management skills while managing multiple projects.
- Self-motivated, with a strong sense of personal responsibility.
- Excellent communication skills, both verbal and written.
- Skilled at working independently and collaboratively in a team environment.
- Proven ability to learn quickly and adapt to new situations.
- Worked well in a team setting, providing support and guidance.
- Worked effectively in fast-paced environments.
- Managed time efficiently in order to complete all tasks within deadlines.
- Passionate about learning and committed to continual improvement.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Assisted with day-to-day operations, working efficiently and productively with all team members.
- Organized and detail-oriented with a strong work ethic.
- Paid attention to detail while completing assignments.
- Learned and adapted quickly to new technology and software applications.
- Proved successful working within tight deadlines and a fast-paced environment.
Education
San Gabriel Mission High School
San Gabriel, CANo Degree -
Saddleback College
Mission Viejo, CASkills
- Quality assurance
- Proficient in Adobe Acrobat
- Data validation
- Document management
- Standard operating procedures
- Document scanning
- Records maintenance
- Skilled in Microsoft Word and Excel
- Information retention policies
- Teamwork and collaboration
- Customer service
- Time management
- Multitasking Abilities
- Adaptability and flexibility
Timeline
Document Controller
Teva Pharmaceuticals
02.2009 - 09.2022
Regulatory Affairs ECTD Submissions
Teva Pharmaceuticals
05.2007 - 02.2009
San Gabriel Mission High School
No Degree -
Saddleback College
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