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The ECQ (Equipment Commissioning and Qualification) contractor supports the successful operation of the GMP facility, laboratory and business functions at multi‐use sites through interaction with internal customers and external service providers. The incumbent in this role will draft, revise, review, route and approve multiple document types in an effort to complete routine activities and meet project milestones. With direction, this individual carries out routine tasks and functions. The individual works collaboratively with their immediate supervisor, team members and internal and external customers to achieve team goals.
1) Technical Writing Responsibilities:
a. Draft, revise, review route and approve Standard Operating Procedures, Work Practices, Forms, and other type of GMP documentation deliverables.
b. Responsible for routing document deliverables through the Client Document Management system.
c. May assist with writing deviations, CAPAs, Change Controls.
d. Facilitate periodic reviews of SOPs.
2) Tracking Responsibilities
a. Keeps a log of documents and their states, including types, owner, reviewers, due dates, etc.
b. Follows up with team members and cross functional team members to encourage timely review and approval.
3) Promotes and provides excellent customer service and support
a. Regularly reviews, prioritizes and promptly responds to customer equipment maintenance, repair and support requests.
b. Provides technical support and guidance on calibration and maintenance issues. Interfaces with customers to ensure expectations are being met.
c. Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
4) Training and Compliance Wire Administration
a. Act as Department Administrator for Compliance Wire
b. Add, remove and update user information
c. Run monthly reports on user training status
5) Record Retention (RR)
a. Act as RR Notification Recipient for group
b. Ensure all department employees are trained on RR
c. Interface with all employees to ensure compliance to RR
d. Maintain accurate documentation of program completion
e. Maintain up to date RR binders
Required Competencies‐Knowledge, Skills, and Abilities:
Knowledge, Skills & Abilities:
• Microsoft Office Suite – Word, Excel, PowerPoint and Outlook with extensive background in database systems. Basic user skills for Excel and PowerPoint are acceptable and they'll use Excel for tracking information. Innate ability to learn new software, such as corporate intranet and enterprise business.
• Understands and works with all components related to web pages, i.e., web parts, lists, pages, libraries, permissions, content and forms
• Strong working knowledge in computer training systems
• Working knowledge of enterprise business systems such as Oracle or SAP preferred but not required.
• Strong written and verbal communication skills. Highly proficient at writing well‐formulated emails and notifications. Ability to effectively communicate with employees, contractors and vendors. Experience with technical writing and document development / generation.
• Excellent interpersonal skills with experience dealing with a diverse workforce.
• Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously
• Familiarity with FDA and EU environments and associated compliance regulations
• Professional Knowledge
• Problem Solving
• Team Player / Building Relationships
• Customer Focus
• Action and detail oriented
• Active Listening
Education & Experience:
• AA / AS degree or acceptable combination of education and practical experience
• Minimum 5 years of Facilities/maintenance/engineering project coordinating / planning experience, preferably in a biotech environment.
Physical / Mental Demands:
• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25lbs
• Ability to sit, stand, walk and move within workspace for extended periods
• Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.
• Primarily office environment
• Ability to work safely and effectively when working alone, or working with others.
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