Document Control Assistant

Cook Myosite Inc.; Pittsburgh (Allegheny County); On-site; USD 42,000 - 64,000; Full time

Job summary

Cook MyoSite Incorporated is seeking a full-time Document Control Assistant in Pittsburgh, PA to maintain the document management system and ensure quality and compliance for document control procedures in a cGMP environment.

The role focuses on supporting GMP manufacturing, controlling the EDMS and MasterControl software, and ensuring timely distribution and archival of controlled documents. Strong organizational and MS Office skills are essential.

Qualifications

• Bachelor's degree in life sciences, business, or related field, or related document control experience.
• Strong organizational skills and the ability to follow complex processes and systems.
• Proficiency in MS Office and effective written and verbal communication.
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations.

Responsibilities

• Supports all activities related to Document Control in GMP Manufacturing.
• Maintains the document control and change management system.
• Serves as document control SME with knowledge of MasterControl and EDMS.
• Oversees daily operations of the Document Control process in MasterControl.
• Maintains files and controls access to original records and documents.
• Formats and proofreads quality system documents.
• Performs document control reviews on quality system records.
• Distributes latest revision documentation to users and removes obsolete docs.
• Supports management during regulatory agency and customer audits.

Skills

Organizational skills

Communication skills

MS Office proficiency

Team collaboration

Education

Bachelor's degree in life sciences, business, or related field

Tools

MasterControl

EDMS

Job description

Document Control Assistant

Job Location(s): Pittsburgh PA United States. Position Type: Full Time. Company: Cook Myosite Inc. Category: Quality

Overview

Cook MyoSite Incorporated, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time Document Control Assistant. The Document Control Assistant at Cook Myosite maintains the document management system and ensures quality and compliance for document control procedures and regulations in a cGMP environment.

Responsibilities

• Supports all activities related to Document Control in GMP Manufacturing
• Maintains the document control and change management system
• Serves as document control subject matter expert and has strong knowledge of the EDMS, MasterControl, software
• Oversees the daily operations of the Document Control process through MasterControl software. This includes but is not limited to creating, revising, collaborating, formatting, approving, and setting effective date for documents
• Maintain files and control access to all original records and controlled documents
• Formats and proofreads quality system documents
• Performs document control reviews on quality system records
• Performs reconciliation and filing of documents
• Distributes latest revision documentation to all appropriate users and ensure that obsolete documentation is removed from distribution
• Fulfill print requests for document distribution locations
• Performs scanning, filing, retrieval, and distribution of documents
• Supporting Management during regulatory agency and customer audits and visits
• Perform various computer applications on MS Office programs
• Perform clerical typing duties to generate documents as necessary
• Maintain regular and punctual attendance
• Must maintain company quality and safety standards
• Exemplifies Cook MyoSite Core Values

Qualifications

• Must have, at a minimum, an undergraduate degree in any life science, business, other related field (BL1) or acceptable related document control experience
• Must possess excellent organizational skills and the ability follow complex processes, procedures and systems
• Demonstrate critical thinking and ability to execute goals set by the organization and Department Manager
• Proficiency in MS Office and other general office equipment
• Must maintain a high level of professionalism, business acumen
• Must have effective verbal, written and interpersonal skills
• Maintain composure and competence under stressful situations; flexibility and adaptability
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing

Physical Requirements

• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Physically capable of standing, stooping, kneeling, climbing, reaching, twisting and bending with or without reasonable accommodation
• Climbing a mobile ladder and/or other types of ladders on occasion with or without reasonable accommodation
• Laboratory and office setting
• Ability to work under specific time constraints
• Must be capable of performing PPE gowning procedures on an occasional basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required on occasion
• General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required

\"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class.\"Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state, and local law.