Position: Document Specialist Office Location: USA (Rhode Island)

PACIV, a global leader in industrial automation solutions with offices in Puerto Rico, United States and Ireland, and servicing the Life Sciences, Food and Beverage, Water/Wastewater and Utilities industries is looking for a full-time employed Document Specialist based at our USA office (Rhode Island).

This role will be integrated with our existing Outsourcing Services Provider (OSP) business model for the Client, which is comprised of a team of PACIV associates executing and maintaining various Validation and Automation tasks and business functions. PACIV’s OSP team is responsible for supporting the client’s commercial facility that manufactures multiple commercial and clinical bulk drug substances by providing seamless support to Quality and Manufacturing operations and their respective groups

Job Description:

This position will support the Information Systems (IS) group to manage and execute the Periodic Review (PR) and User Access Request (UAR) processes for automated systems. These systems are subject to Good Manufacturing Practices (GMP) in a highly regulated environment. The expectation of this role will be to become an expert in the process of PRs and UARs. Day to day work will include interfacing with various business owners and technical subject matter expects, writing PR documents, processing UAR forms, and staying current on prescribed computer-based training plans. The ideal candidate will have a proactive and systematic approach to daily work, excellent verbal and written communication skills, and high attention to detail.

Position Responsibilities/Essential Functions:

• Responsible for ensuring the PR process is completed for a given asset within two months of the date a review is opened. Expectation will be to thoroughly understand the applicable Standard Operating Procedures and become a subject matter expert on the process of executing the periodic review.
• Ownership of each PR, including ensuring business and technical representatives provide input for the completion of each periodic review. Requires developing a rapport with key stakeholders in the process to acquire information and ensure deadlines are met.
• Provide visibility of the status of each assigned PR in weekly departmental meetings to escalate issues and drive completion.
• Responsible for processing UARs for a variety of automated control systems, including but not limited to: Pharmaceutical Production Systems, Utilities Systems, Instrumentation, Building Management Systems.
• Access Rosters for the various systems will be periodically reviewed to ensure users are compliant and should retain access to the systems. Will require coordination with business owners, system administrators, and user managers to maintain active access rosters to the various systems.
• Utilize various systems for data and information queries (MAXIMO, Trackwise, QDocs, etc.). Execute PRs and user access requests within the defined document repository systems for document management and control.
• Prepare, submit, and present weekly status reports of PRs and system UARs.
• Maintain the assigned computer-based training plan to 100% completion.

Requirements:

• High School Diploma or GED with five (5) years of professional experience in document control or technical writing.
• A.S. or B.S. Degree with two (2) years of professional experience in document control or technical writing.

Preferred Qualifications:

• Must be able to drive assignments to completion and collaborate with cross functional teams to drive decisions to support documentation completion.
• Works well with others, within a team and takes accountability
• Can handle a high-pressure, high-stress work environment
• Familiarity and capability with document control systems (QDocs, Veeva Vault, etc.)
• Ability to Query databases for applicable data (MAXIMO, Trackwise, etc.)
• Experience in a highly regulated and/or pharmaceutical environment is preferred.
• Result driven and self-motivated
• Strong interpersonal and communication skills (verbal and presentation)
• Organized, with strong computer literacy such as MS Project, MS Excel, etc.

Other Requirements:

Location: Rhode Island

Travel: No travel anticipated.

Compensation:

Competitive Salary and Benefits Package, which includes:

• Paid Time Off (PTO) for vacation, sick, and company holidays
• PTO is earned on an accrual basis throughout the calendar year
• Health Insurance
• PACIV pays 90% of the premium for the health insurance plan. Monthly contributions made by PACIV and are distributed through an HSA (Health Savings Account)
• $25,000 Basic Life Insurance Plan for all full-time employees, with additional plan options offered at the employee’s cost
• 401(k) Retirement Plan with company match
• Project Performance Bonuses (for qualified projects and employees)