Document Control Specialist

REQUIREMENTS:

Experience with Quality System Documentation and good documentation practices

Knowledge of ISO, FDA and cGMP concepts and guidelines.

Strong communication, prioritization and organizational skills.

Excellent writing skills.

Work on complex assignments in collaboration with various department system owners.

Analytical problem solving and organizational ability.

Strong interpersonal skills and ability to work with others in a positive and collaborative manner.

Must demonstrate ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.

Ability to utilize multiple word-processing and database applications including MS Office applications Word, Excel, Access, as well as Adobe Acrobat, etc.

Works under minimal supervision.

ESSENTIAL DUTIES, RESPONSIBILITIES AND AUTHORITY:

Coordinate the activities of Document Control, including distribution and auditing controlled documents, maintenance of electronic department directories, tracking and reporting on document review progress.

The Document Control department personnel shall ensure all items below are satisfactory, but not limited to;

· Work independently to facilitate group activities

· Manage archival activities for controlled documents and validation files

· Assist with the implementation, management and administration of the department electronic document management system (IQMS)

· Work with subject matter experts on technical subjects in a positive, collaborative manner to prepare controlled documents which conform to Marman Industries, Inc.’s defined format

· Review and proofread documents for consistency of document format and system concerns such as device master records

· Create change orders and ensure the change orders are signed by the appropriate departments prior to issuing drawings, specifications or any other documents in the document control database.

· Issue and document calibration auxiliary numbers to QC or production personnel upon request.

· Document environmental results

Use department databases to track and manage and control issued documents. Effectively follow SOPs, policies, and cGMPs. Provide support for the Quality System during corporate audits, actively participate in department activities

Adhere to and enforce Marman Industries, Inc. policies and procedures related to document control

Perform audits of company areas and processes to confirm compliance with controlled procedures

STANDARDS DUTIES AND RESPONSIBILITIES:

Follow applicable company dress code.

Must follow all general safety rules.

Must be willing to attend job-related seminars.

Perform other tasks or duties as assigned.

DESIRED PERSONAL CHARACTERISTICS:

Assertive personality

Competitive attitude.

Committed to the highest quality.

Be a courteous and professional team player.

Professional, well-organized, and eager to learn and be challenged.

PHYSICAL REQUIREMENTS:

Must perform all tasks in a fast pace environment.

Job Type: Full-time

Pay: $24.00 - $28.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• AD&D insurance
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Work Location: In person

Salary : $24 - $28