Description
The Documentation and Documentation Systems Coordinator is a key member of the Pearl River team, responsible for coordinating and managing documentation and documentation systems at the Pearl River site.
The role involves system coordination for engineering and operations documentation management systems, including Computerized Maintenance Management System, Electronic Logbooks System, Master Batch records, and Standard Operating Procedures.
Responsibilities:
- Develop data elements in the CMMS for support of engineering and maintenance, including equipment details, maintenance plans, maintenance schedules, and work order task plans.
- Administer the CMMS system.
- Author, review, and approve Master Production Batch Records to support manufacturing operations.
- Author, review, and approve electronic logbooks and logbook forms in SDS.
- Author, review, and approve standard operating procedures to support engineering and manufacturing operations.
- Manage Change Requests, Change Notices, and Periodic Review of production and engineering documentation.
- Coordinate commitment and quality drivers for MBR, FORMS, Maintenance Tasks, and SOP updates.
- Review and file executed maintenance and production documents in coordination with the QARM documentation group.
- Manage and review data in PGS electronic documentation systems.
- Coordinate issuance of and reconciliation of cGMP maintenance plans, SOPs, Forms, and MBRs.
- Support regulatory/internal audits.
Requirements:
- Associate's degree with 5+ years of experience or Bachelor's degree with 2+ years of experience or Master's degree with any years of relevant experience.
- Strong sense of ownership and accountability.
- Excellent organization and time management skills.
- Demonstrated ability to effectively collaborate with team members within and across functions.
- Knowledge and experience of cGMP and FDA rules and regulations.
- Proficiency in data analysis and trend monitoring with knowledge and experience with technologies digital systems used in the pharmaceutical industry.
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot.
Benefits:
- Comprehensive and generous benefits and programs to help colleagues lead healthy lives and support each of life's moments.
- 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
- Paid vacation, holiday, and personal days.
- Paid caregiver/parental and medical leave.
- Health benefits, including medical, prescription drug, dental, and vision coverage.
Salary:
- The annual base salary for this position ranges from $82,700.00 to $137,900.00.
- Bonus target of 10.0% of the base salary.