Scope of Position

The QA Associate - librarian ensures compliance with cGMPs, internal policies, procedures, and specifications. This position is responsible for performing document control management (a.

k.a. Central Archives) for GMP-related documents in various mediums (e.g. digital, paper) by cGMPs and related company SOPs, state, federal and local laws, as applicable.

Responsibilities

• Provide the real-time status of documents through their lifecycle, which may include : authoring, versioning, issuance, archival, periodic review, or destruction, as stated in the most current version of the governing SOP(s) and QA Central Archive Management for GMP related documents in any medium.
• Support the issuance, compliantly document, and reconcile the delivery of QA-Controlled documents. Conduct periodic reconciliations to ensure QA-Controlled documents are appropriately accounted for and discrepancies are procedurally addressed.
• Coordinate inventory of office supplies needed or recommended for the administration of documents and the QA group.
• Organize and / or maintain clean, neat, and fit-for-purpose areas, across multiple sites so that colleagues can easily find resources as needed.

Taking into consideration the sensitivity of specific documents and ensuring documents are access controlled, as needed.

• Identify opportunities to improve and make recommendations.
• Support requestors to easily check in and check out material so that inventory is accurate, and status is retrievable in real-time.

Provide periodic reconciliation to ensure materials checked out are promptly returned after their use.

• Respond to various requests from various channels (e.g., email, phone, enterprise instant messenger (IM), in-person) and manage the requests based on priority.
• Coordinate the archival process, with area owners and facilitate the shipping, delivery, and inventory of documents with our offsite document storage provider.
• Perform other duties as assigned by supervisor.

Qualifications

• One or more years of relevant work experience in an Administration or Document Control role. (Bachelor’s degree or higher, in Life Sciences, Pharmacy, Operations, Quality, Business Administration, Library Science, Communications ).
• Familiarity with Microsoft Applications such as Outlook, Word, Excel, PowerPoint, Access, Project, OneDrive, etc.
• Proficiency in working effectively independently
• Excellent oral and written communication.
• Ability to manage multiple priorities and re-prioritize tasks as required.
• Excellent problem-solving skills.
• Experience working knowledge of library practices is preferred.
• Willingness and ability to be flexible, creative, and innovative.
1 day ago