What are the responsibilities and job description for the Facilities Documentation Specialist position at Sharp Clinical Services?
SUMMARY:
The Facilities Documentation Specialist will serve the Sharp Allentown Facilities Services Department as a Subject Matter Expert (SME) in Veeva Vault Quality Management System (Veeva), Blue Mountain Regulatory Asset Manager (BM RAM) and Chrome River (CR) / Emburse Enterprise, supporting the operation, maintenance and improvement of (1) 210,000 ft2 warehouse and (3) cGMP pharmaceutical packaging buildings totaling 320,000 ft2. The Facilities Documentation Specialist will report to the Director, Facilities.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Quality:
- Create and update Facilities Standard Operating Procedures (SOPs), Work Instructions (WRKIs), Quality Forms (QFs), etc. in Veeva.
- Create, actively monitor progress and take action to ensure the prompt closure of Facilities and related Change Control Records (CCRs) in Veeva.
- Create Facilities and related Non Conformance Records (NCRs) in Veeva, and collaborate with Investigators to aid in their efforts to conduct thorough investigations.
- Assist with timely creation and execution of Facilities Departmental Analyses (DAs), Effectiveness Checks (EFFs), etc. within Veeva.
- Complete Facilities Action Items (AIs) in Veeva as assigned and on-time. Shepherd all Facilities AIs to on-time completion in Veeva. Track any late Facilities AIs to prompt completion in Veeva.
- Support customer and FDA audits by responding to questions and describing duties as outlined in this Job Description, as well as Facilities procedures and processes as outlined in the salient SOPs, WRKIs, QFs, etc.
- Foster effective partnerships with all Quality personnel.
- File extension requests in Veeva when necessary.
Maintenance:
- Create on-demand Work Requests in the BM RAM Computerized Maintenance Management System (CMMS) as needed.
- Collaborate with the Manager, Facilities – Hard Services to create and update PM Plans / Work Instructions as needed.
- Collaborate with the BM RAM System Administrator to create Asset IDs as needed.
- Collaborate with the Manager, Facilities – Hard Services to assign all monthly PMs to Facilities Mechanics.
- Generate all monthly PM assignments and calibrations for all vendor partners. Schedule those vendor partners to perform PMs and calibrations to align with room availability as determined by the Sharp Integrated Business Plan (IBP) process so as to complete, document and close all work on or ahead of time.
- Proactively manage healthy relationships with all vendor partners.
- Assist in planning and support major shutdowns and site work which impacts large portions of the site or the entire site.
- File extension requests in BM RAM when necessary.
Procurement:
- Solicit proposals and quotations from vendor partners.
- Create Purchase Orders in CR.
- Approve Invoices in CR.
- Shepherd the process to approve new Sharp Facilities vendor partners.
Reporting:
- Gather Facilities maintenance and operations data. Analyze that data against established KPIs (Key Performance Indicators). Report progress against those KPIs on a monthly basis.
- Gather Facilities quality data. Analyze that data against established KPIs. Report progress against those KPIs on a monthly basis.
Other:
- Share information, collaborate and coordinate with other resources as necessary including, but not limited to, Sharp Facilities Mechanics, Sharp and temporary Housekeepers, members of Sharp’s Mechanical & Electrical Services Group, Sharp employees at other Sharp commercial and clinical packaging sites, vendor partner personnel, etc.
- Identify, collect, upload and maintain accurate and up-to-date documentation related to facilities.
- Comply with all Sharp safety rules, policies, and procedures.
- Perform other related duties as assigned.
QUALIFICATIONS:
- Familiarity with one or more CMMS tools, one or more QMS tools, one or more Procurement tools and the full MS Office Suite of tools is required. AutoCAD experience is desired.
- Well-versed in the preventive, predictive & corrective maintenance and operation of industrial and commercial equipment, especially HVAC.
- Ability to read and interpret drawings, blueprints and specifications.
- Excellent analytical and problem-solving skills.
- Strong technical skills and attention to detail.
- Solid verbal and written communication skills to a broad audience.
- Robust time management and organizational skills.
- Ability to quickly adapt to changing priorities and assignments, and shift work schedules and staffing accordingly.
SUPERVISORY RESPONSIBILITIES:
None
PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:
- A 2-year degree in Engineering, Facilities Management or a related technical field is required; a 4-year degree is preferred.
- CFM, FMP or similar Facilities Management certification is desired.
- 3-5 years of experience as a Facilities Documentation Specialist is required.
- Biopharma experience in a cGMP environment is strongly preferred. Otherwise, experience in a regulated environment is desired.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
DISCLAIMER:
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
