Document Control Specialist

About the Organization Associates of Cape Cod, Inc. (ACC) Your Endotoxin Experts! Manufactures bacterial endotoxin and beta-glucan detection products. The Company offers enzymes, muco-polysaccharides, monoclonal antibodies and glyco-conjugates, endoglycosidases, and exo-glycosidases, as well as limulus amebocyte lysate products. ACC serves customers worldwide.

PURPOSE: Maintain Document Control systems and activities in compliance with ACC policies and procedures, QSRs and 13485

GENERAL RESPONSIBILITIES:

• Maintain all Document Control procedures in an updated and accurate manner and implement all activities as required;
• Maintain Document Control databases and logs such that they are up to date, efficient, and accurate at all times;
• Maintain distribution logs for controlled documents in Electronic Document Management System or other logs as appropriate;
• Ensure that controlled documents are kept up to date and issued as appropriate, and superseded documents are retrieved to prevent inadvertent use;
• Maintain and control archive storage locations such that they are kept up to date and organized for ease of retrieval of records, and in a manner that prevents damage and misuse. Scan records as appropriate;
• Organize and log records to be sent for offsite storage, and communicate with supplier when retrieval is needed;
• Follow Record Retention procedures and ensure shredding is documented as appropriate and includes the required approvals;
• Maintain accountability for issuance and verification of control numbers (i.e. lot numbers) per procedures;
• Prepare documents for use in a timely manner such as Production binders (PHR's), in-process paperwork, kitting and packaging requests, etc;
• Review and release Item Masters into GP;
• Enter lot information into the Labeling databases per procedures;
• Maintain Level 0 Documents (regulatory standards, guidance's, etc) per procedures and ensure logs and review forms are completed;
• Scan and upload certificates of analysis and certificates of compliance for Customer Service and website as appropriate, per procedures;
• Author, review, process and close document changes in a timely manner, ensuring compliance with applicable procedures;
• Participate in training related activities, including but not limited to LMS administration activities, conducting training, and participating in assigned training;
• Participate in and complete all projects and Quality System assignments in a timely manner and to meet the requirements of the procedures;
• Maintain and support administration of systems and services utilized by Document Control including but not limited to GMP training, Standard subscriptions, and Shredding services.
• Support generation of monthly reports;
• Support and prioritize all Document Control related activities and requests for records;
• Prepare for, support, and participate in customer, regulatory, and internal audits;
• Support software media production and MD5 verification activities;
• Review and approve CTS reports as a backup, as required; and
• Other duties as assigned.

KNOWLEDGE AND SKILL REQUIREMENTS:

• Working knowledge of cGMP, ISO 13485 and principles of document control.
• Detail oriented and excellent organizational skills.
• Ability to work in a fast paced team environment.
• Ability to work on multiple tasks and meet deadlines.
• Excellent oral and written communication skills.
• Proficiency in all office based software.

EDUCATION AND EXPERIENCE:

• A minimum of an Associates Degree or equivalent combination of experience and/or education required.
• Minimum of 1-3 years experience working in an FDA and/or ISO regulated environment or equivalent combination of experience and/or education required.

GENERAL

COMPETENCIES:

• Communicates well (written and verbal), delivers presentations, has good listening skills
• Perform tasks with a computer. Email, research, interaction with others via the internet. Creating and editing documents typically utilizing MSOffice; word documents, spreadsheets and create a slide presentation (PowerPoint). The level of proficiency is defined by the requirements of the position held.
• Good listener, committed to finding solutions to problems, works well with difficult people
• Works well with internal and external customers, promotes a positive image of the company, and strives to solve issues raised by customers.
• Meets deadlines, works independently, accountable, maintains focus, punctual, good attendance record.
• Honest, accountable, maintains confidentiality.
• Information, organized and accessible, maintains…