Document Control Specialist

ClinLab Staffing; Buffalo (NY); On-site; USD 75,000 - 85,000; Full time

Job summary

An established industry player is seeking a Document Control Specialist to enhance their quality management system. This role involves overseeing documentation processes, ensuring compliance with quality standards, and collaborating with various teams to draft and revise essential policies and procedures. The ideal candidate will thrive in a fast-paced environment, possess strong attention to detail, and have excellent communication skills. Join a dynamic team dedicated to maintaining high-quality standards in a growing organization that values innovation and teamwork.

Qualifications

• 2-5 years of experience in developing and maintaining procedures.
• Strong computer literacy with proficiency in Microsoft Excel.

Responsibilities

• Assist in drafting and revising policies and procedures.
• Administer the document approval and release process.

Skills

Document Management Software

Microsoft Office Suite

Data Analysis

Attention to Detail

Communication Skills

Education

High School Diploma or Equivalent

Tools

MasterControl

Job description

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The document control specialist provides support to all areas of the organization by overseeing the documentation and records process including, the review, release and revision of policies, procedures, and documentation related to the entire quality management system.

Key Responsibilities:

• Assist process owners, engineers and technicians with drafting, implementation and revision of policies, procedures, and work instructions.
• Create and revise documents (writeable forms, work instructions, and spreadsheets).
• Administer the document approval and release process.
• Update, controlled documents (retrieval, distribution, archiving, storage and obsoleting).
• Ensure maintenance of internal and external controlled documents, approvals, and implementation of the document changes into the document control system.
• Issue production records to manufacturing teams.
• Utilize advanced Microsoft Office Suite to promote consistent formatting of all documentation
• Performs other duties as assigned.

Education:

• High School diploma, General Education Degree, or equivalent

Experience:

• 2-5 years of prior relevant experience developing and maintaining procedures and work instructions and other documentation

Minimum Requirements/Qualifications:

• Experience in using document management software, such as MasterControl.
• A solid understanding of quality management system systems and their documentation requirements.
• Strong computer literacy, including Microsoft Office Suite (Proficiency in Excel – experience with setting up spreadsheets with pivot tables is a plus).
• Data Analysis and reporting skills.
• Ability to pay close attention to detail
• Work well within a team and maintain pace while ensuring high quality standards. Assist other team members, as needed, to ensure customer satisfaction
• Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints
• Excellent communication skills, both written and verbal, to communicate to all levels of the organization clearly and concisely
• Strong work ethic and an ability to excel within a rapidly changing and growing organization

Physical Requirements/Working Conditions:

• Ability to stand and/or walk constantly over a full work shift (8-12 hours)
• Ability to perform occasional to frequent pushing, pulling, bending, kneeling, twisting, crawling and/or reaching over a full work shift (8-12 hours)

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Science

• Industries

  Biotechnology Research, Pharmaceutical Manufacturing, and Medical Practices

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Senior Document Management Specialist - Onsite

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