Document Control Associate I job in

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SECTION 3: EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS (List requirements in bullet format. For all positions, regardless of location, the American with Disabilities Act (ADA) paragraph must be included. Information pertaining to the ADA is included in the Job Description Form Guidelines)
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. US only - A minimum of 2 years document control or other relevant administrative experience in the pharmaceutical or CRO industry. EU only - Prior relevant document control or other relevant administrative experience in the pharmaceutical or CRO industry. Strong computer skills, especially in MS Word, Excel and Power Point. Good oral and written communication skills. Detail-oriented, with excellent organization and planning skills. Team player with ability to follow directions/instructions. Ability to work in a fast-paced environment with minimum supervision.

SECTION 1: POSITION SUMMARY

Maintain and track quality system documents in accordance with regulatory and company guidelines.
Assist with formatting, publishing, circulating and distribution of quality system documents.
Assist the Quality Assurance department with functions related to document control and the EDMS, as required.
Oversee the physical document archival process (ICL only).

SECTION 2: JOB FUNCTIONS/RESPONSIBILITIES

(List statements in bullet format. Put an asterisk* next to each essential function. The definition of an essential function is included in the Job Description Form Guidelines.)

Recognize, exemplify and adhere to ICON's values which centers around our commitment to People, Clients and Performance.
As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
Travel (approximately 0%) domestic and/or international
Process new/revised documents for review and approval, including review and verification of documents for completeness, accuracy and compliance with company guidelines and processes.*
Manage document distribution activities.
Initiate and track periodic review of documents.*
Maintain an index of documents and forms.
Perform system maintenance for user accounts in the EDMS.*
Oversee proper storage and archive of documents; prepare documents for archival and maintain archival space (ICL only).
Conduct internal audits of Document Control as required.
Interface with ICON community as needed by applicable communication (i.e., phone, e-mail, etc.).
Undertake other duties as may be assigned from time to time.
Keep the person to whom the Document Control Associate reports informed of any QA issues within the department that require attention.

SUPERVISION

(List statements in bullet format. Put an asterisk* next to each essential function.)

N/A

SECTION 3: EXPERIENCE, SKILLS, KNOWLEDGE REQUIREMENTS

(List requirements in bullet format. For all positions, regardless of location, the American with Disabilities Act (ADA) paragraph must be included. Information pertaining to the ADA is included in the Job Description Form Guidelines)

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
US only - A minimum of 2 years document control or other relevant administrative experience in the pharmaceutical or CRO industry.
EU only - Prior relevant document control or other relevant administrative experience in the pharmaceutical or CRO industry.
Strong computer skills, especially in MS Word, Excel and Power Point.
Good oral and written communication skills.
Detail-oriented, with excellent organization and planning skills.
Team player with ability to follow directions/instructions.
Ability to work in a fast-paced environment with minimum supervision.

SECTION 4: EDUCATION REQUIREMENTS

(List requirements in bullet format.)

High School Diploma or local equivalent.

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At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential.
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Document Control Associate I

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