Document Control Manager oversees document and record control operations, policies, and procedures for the secure management and access of company information assets. Establishes security protocols for the access, storage, backup, maintenance, reproduction, protection, and disposition of all documents. Being a Document Control Manager evaluates media formats and recommends storage requirements to protect and secure records/information. Develops and manages access and control procedures to comply with requirements for varying levels of security classifications specified by the governing authority. Additionally, Document Control Manager maintains auditing, monitoring, and change control systems to ensure document integrity, quality, and version control. Typically requires a bachelor's degree. May require security clearance. Typically reports to a director. The Document Control Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Document Control Manager typically requires 5 years experience in the related area as an individual contributor. 1-3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Are you ready to join a growing, global drug development and manufacturing organization that puts people first?
Come to Adare!
We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world.
Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success.
With the help of people like you dedicated to our mission, Adare is
Adare !What can Adare offer you?Medical / dental / vision / life low employee premiums401k with a highly competitive matchGenerous PTO, including floating holidaysCareer growth and internal opportunitiesTuition reimbursementRelocation assistancePerformance-based bonusEmployee Recognition ProgramsWe are seeking to hire a
Document Control Associate
to join our
Quality
Team.If any of the below describes you, we would love to meet you!RESPONSIBILITIES AND LEARNING OPPORTUNITIESIssue and print Batch Manufacturing Records to production to align with the manufacturing schedule at various sites.
Maintain the appropriate files and logs.Review documentation for completeness.Process, track and retrieve SOPs, protocols, reports, policies, etc.
using an electronic document management system.
This includes obtaining electronic review and approval of documentation.Prepare SOP’s being made effective. Supersede or obsolete previous revisions.
Update SOP Book Sets accordingly.Control the issuance / distribution of SOP attachments and other executable documentation.
Track and document accordingly.Prepare and track various documents for training.Compile documentation related to manufacturing changes for Annual Product Reviews (APRs).
Also, scan, bookmark and archive APRs. Scan documentation and prepare for archival. Log and prepare documents for destruction.
Utilize the retention database to enter and retrieve records. Box up and relocate archived boxes of documents to / from various site locations.
Prepare logbooks according to SOP’s. Issue to applicable departments and maintain tracking log.
Archive completed logbooks. Maintain physical files, paper book sets and master files.Process, distribute, file, track, retrieve, copy and archive a variety of documents manually when needed.
Distribute documents to various departments within the company and document accordingly.Provide administrative and clerical support.
Perform other duties as assigned.College degree preferred with some related experience or High School diploma coupled with 2 years related experience.
cGMP documentation experience preferred.To perform this job successfully, an individual must possess excellent typing ability and computer skills as well as oral and written skills.
Individual must be proficient in Microsoft Office applications such as Word and Excel.Electronic document management experience is preferred.
Strong organizational skills are necessary to manage multitask activities.Detail oriented, especially with regards to proofreading, required to ensure accuracy and completeness of documentation.
Medical / dental / vision / life low employee premiums401k with a highly competitive matchGenerous PTO, including floating holidaysCareer growth and internal opportunitiesTuition reimbursementRelocation assistancePerformance-based bonusEmployee Recognition ProgramsAdare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity / expression, national origin / ancestry, age, disability, marital & veteran statusPRINCIPALS ONLYNO AGENCIES OR THIRD PARTIES.
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Last updated : 2024-04-08