Document Control Specialist - Cumberland, United States - NEUROTECH U S A

NEUROTECH U S A Cumberland, United States

1 week ago

Description

Job Description

Neurotech Pharmaceuticals is an innovative biopharmaceutical company located in Cumberland, RI, within the realm of Greater Boston's vast biotechnology landscape. Since our inception more than 20 years ago, we have been developing a proprietary biological drug device combination technology for treatment of a variety of retinal disorders. Our most advanced program is developing a treatment for the orphan disease Macular Telangiectasia Type 2 (MacTel). Our Encapsulated Cell Technology (ECT) platform is designed to deliver a genetically modified neuroprotective factor to slow the progression of this chronic retinal disease.

We are currently seeking a Document Control Associate to support the Lead Document Control Specialist and help control department operations and processes while providing support in the communication of the activities of the Document Management team to a cross-functional audience. This includes document oversight supporting the following areas: document workflows, records issuance, technology, inspection readiness, continual improvement, inspection support, projects planning, logistics and metrics. This role will ensure partnerships are built and maintained within the functions Document Control supports to drive high quality throughput via efficient and effective methods of GDP and document control.

This is an on-site role in Cumberland, RI. This is not a hybrid or remote opportunity.

Also, please note this role is not eligible for agency recruiting support.

Job Requirements

Help improve the Document Control processes ensuring that performance and quality conform to regulatory standards and internal requirements.
Help manage document system revision control to ensure compliance based on business need.
Support the processing, archival, filing, scanning, indexing, and formatting of new and existing documents within guidance of the document control procedures via the document management system (DMS).
Provide support to the Quality organization as required including Scanning, PDF creation and loading into secure location and updating secured lists.
Help manage company records repository that tracks the cataloging, archiving, retrieving, and dispositioning of all GxP documents.
Ensure timely prioritization of work and projects and adequate resource availability.
Support the partnership of cross-functional departments to ensure alignment of processes, systems and procedures within document control, and continuous improvement and user experience within the document system at Neurotech.
Collaborate and communicate cross-functionally to improve the overall efficiency and effectiveness of our document system.

Education & Experience

To be considered for this role you need a bachelor's degree and a minimum of 2 years' experience working in a GMP-regulated manufacturing environment.
Thorough knowledge in industry practices and regulations (cGMP, Annex, ICH, etc.) and across multiple health authorities.

Knowledge, Skills & Abilities

Thorough understanding and technical experience in Document Control/Information and Records Management operations and methodologies.
Extensive experience in analyzing information of considerable complexity and drawing valid conclusions.
Proficient in Microsoft Office Suite including Excel Word and Outlook.
Ability to be flexible with work assignments to meet the needs of the department.
Experience with a document management system (e.g.: Trackwise).
Ability to excel in a high-energy, fast paced environment and able to keep up with changing priorities.
Proficiency in operating photocopying and scanning equipment.
Strong interpersonal skills with the ability to help drive an active and compliant quality culture.

In addition to a talented and passionate team of colleagues and unparalleled science and technology, Neurotech offers competitive compensation, benefits through Blue Cross BlueShield and HealthEquity (FSA, HSA & HRA), a 401(k) through Fidelity with a company-sponsored match, generous vacation time and company holidays. We even cover the cost of 75% of your annual medical plan deductible And that's just the beginning.

Do you share our vision?

Neurotech Pharmaceuticals provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Please note, Neurotech does not accept unsolicited résumés or candidate profiles. If a candidate submitted in this manner is hired, no placement fee will be paid.

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