Dynamic, highly motivated, achievement oriented individual seeking a position as Document Control with a progressive organization in which strength of character, personal abilities and notable experience are greatly valued. Highly effective at managing reporting requirements and solving problems in tumultuous environments. Position should allow for continued growth and advancement commensurate with contributions.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Document Control Specialist
Lonza
12.2019 - Current
Actively supported the Document Management System (DMS), facilitating document implementation and migration while issuing catalog/database control numbers to ensure compliance with cGMP standards
Formatted, reviewed, and managed approvals of Standard Operating Procedures (SOPs), technical manuals (TMs), and templates, contributing to effective document control processes
Assisted in the full lifecycle of documentation, including creation, editing, review, issuance, and archiving of lab journals, research reports, batch records, and SOPs, ensuring adherence to regulatory requirements
Logged document requests and assisted coworkers with document disposition tasks to streamline workflow and ensure compliance with company procedures
Planned and led small projects, ensuring compliance with company specifications and regulatory standards in a fast-paced environment
Collaborated closely with managers, project leaders, and other departments to ensure effective document control and compliance with internal processes
Document Control Associate
Accentia Biopharmaceuticals
10.2017 - 12.2019
Scanned, stored, and audited electronic and hardcopy documents for customer inquiries, audits, and inspections, verifying compliance with cGMP and industry regulations
Prepared documentation and data for audits and inspections, ensuring alignment with company standards and effective communication with internal and external stakeholders
Managed departmental documentation, log-sheets, and maintained batch record formats, consistently auditing documents to ensure accuracy and compliance
Identified compliance/non-compliance in GMP documentation and recommended amendments to improve processes
Authored and maintained SOPs, collaborating closely with subject matter experts to manage templates and document revisions
Provided training to staff on the use of document management systems and processes, enhancing team competency in documentation practices
Developed skills in interpreting non-standard processes and applying GMP regulations to ensure compliance
Ran database queries and generated reports, performing data entry as required to support documentation efforts
Reviewed completed batch and cleaning records for accuracy and compliance with regulatory standards
Entered new employees into the portal system and initiated their training to maintain compliance with training requirements
Updated training and testing curricula to reflect document revisions, ensuring all staff are informed of current practices
Extensively utilized Excel and Word for formatting, creating, and storing electronic data, supporting effective document management
Supported administrative tasks for deviation management, investigations, and change requests to ensure compliance with operational standards
Assembly Line Worker
SMR Automotive
06.2016 - 10.2017
Performed all stages of assembly for automotive side mirrors within an allotted amount of time
Maintain good social interaction and team-player spirit to boost morale and product output
Analyzed project requirements to find errors and eliminate issues within a timely manner
Set and achieved product quality objectives while meeting product specifications
Troubleshoot faults and devised successful solutions in a self-directed manner
Cell Phone Technician
Sam’s Club
03.2015 - 05.2016
Promotion of carrier phone plans and technological support
Checked cell phones for signs of fraud and compatibility with refurbishment
Responded to customer requests and navigated to a solution together
Consulted with upset customers to determine best resolution to service and billing issues