Saliha Johnson
Merck
Lansdowne,PA
Experienced documentation professional with over 13 years in SOP revision, records management, and quality assurance within regulated environments. Enhanced GMP and CGMP documentation processes for pharmaceutical teams, ensuring integrity and compliance. Developed training programs for cross-functional teams on standards and templates, fostering effective execution. Detail-oriented senior specialist with a strong background in records management, archival procedures, and document integrity. Trusted to administer access rights, verify data accuracy, and support Merck teams with compliant documentation. Ready to bring dependable quality control and process improvement to a regulated environment.
14
years of professional experience
Work History
Senior Documentation Specialist (Contractor)
13 Years 8 Months
Merck - Philadelphia, Pennsylvania | 04.2013 - 12.2026
- Ensured documentation quality standards for accuracy, consistency, and compliance with Merck standards.
- Ensured that all documents were compliant with GMP & cGMP standards as well as applicable laws and regulations.
- Reviewed batch records to ensure compliance with Merck quality standards.
- Supported Merck pharmaceutical teams with GMP documentation and SOP updates.
- Administered document access and revision rights to personnel to maintain documentation integrity.
- Set up, optimized and enforced consistent document management policies.
- Trained staff on documentation processes, templates, and quality requirements.
- Trained new team members on required processes to ensure performance goals were met.
- Verified accuracy and integrity of supplied data against established standards.
- Monitored activities to assess compliance with records policies and document management regulations.
- Coordinated cross-functional tasks with Merck research and operations staff.
- Identified process gaps, implemented solutions to enhance operational efficiency.
- Identified department and user document management requirements by conducting in-depth needs assessments.
- Supported Automation documentation workflows for policies, procedures, and client records.
- Revised SOPs and work instructions in Microsoft Word and SharePoint.
- Maintained confidential records within Merck compliance standards and procedures.
- Assisted audits by organizing Merck files, forms, and source documents.
Education
High School Diploma
Overbrook High School - 5898 Lancaster Ave. Philadelphia, PA 19131
06-1997
- Course Completion Certificate in Control Storage and Archival of GMP Documents Training
- Course Completion Certificate in Data Integrity – Data Owner Training
Skills
GMP compliance
SOP revision
Records management
Workflow management
Archival Procedures
Cross-functional teamwork
Operational efficiency
Workflow efficiency
Timeline
Senior Documentation Specialist (Contractor)
Merck
04.2013 - 12.2026Read more
Overbrook High School - High School Diploma,
Read more