True Job Title: Senior Quality System Documentation Specialist
Max Bill Rate: $80.00/HR (have some flexibility here)
Contract Duration: 12/31/2021 (although if budget allows we could extend into 2022 if required)
Scope of Work:
Assess quality system documentation stored within the Electronic Document Management System (EDMS) to identify opportunities for improvement, including
• the correct placement of content at the appropriate level of the quality system document hierarchy, e.g. Policy, Standard, Procedure, Instruction
• documents that are clear as to their purpose, scope, and intended audience
• the removal/consolidation of obsolete, redundant, duplicate or overlapping documentation
• documents that are structured to support efficient role-based training assignments
Facilitate resolution of identified improvements by securing agreement for, and coordinating completion of, proposed document revisions in collaboration with the relevant document owners and quality assurance oversight.
Experience Level / Type:
Years of Experience: 5 to 7 years of relevant experience in the pharmaceutical industry
Subject matter expertise, and direct hands on experience with the implementation and maintenance of quality system documentation in a GxP regulated environment.
Direct experience with the design and implementation of role-based training curricula a GxP regulated environment.
Direct experience using Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS) in a GxP regulated environment
Knowledge of IT operations, and the compliant management of validated computer systems.
Excellent communication, analytical, and organizational skills, using modern technology platforms. Strong verbal, technical writing and interpersonal skills.
Intake Notes:
Interview Process:
Hiring Manager (Brendan Daly) interview, via Zoom video conference
Potentially a second interview from a colleague of mine in IT Quality Assurance department
Remote: Remote is acceptable
Years of Experience: 5 to 7 years of relevant experience in the pharmaceutical industry
Top 3 Skill Sets:
a. Subject matter expertise, and direct hands on experience, with the implementation and maintenance of quality system documentation in a GxP regulated environment.
b. Direct experience using Electronic Document Management Systems (EDMS) in a GxP regulated environment.
c. Excellent communication, analytical, and organizational skills, using modern technology platforms. Strong verbal, technical writing and interpersonal skills.
Top 3 Nice to Have Skill Sets
a. Direct experience with the implementation and maintenance of role-based training curricula in a GxP regulated environment.
b. Knowledge of IT operations and the compliant management of validated computer systems.
Unique Selling Point of this role:
An opportunity to lead an improvement project with direct impact on the efficiency of IT operations
Onsite Offsite: Offsite
Have you already identified a candidate: No
Pre-Identified Candidate result: End Pre-Identified Candidate
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