Document Control Specialist

Summary:

The Document Control Specialist oversees and continuously improves the company’s document control management system to ensure that processes comply with internal procedures and regulatory requirements.

Responsibilities:

• Establish, implement and direct procedural framework for formatting, storing, updating, identifying, collecting, distributing and filing controlled company documents. This includes writing, reviewing, and maintaining document control procedures.
• Create and update Standard Operating Procedures, Work Instructions, forms and logs specific to the document control processes, physical and electronic.
• Circulate controlled company documents for approval signatures.
• Responsible for distribution/notification of document release, change and obsolescence.
• Audit and review company document changes for accuracy and completion.
• Effectively provide guidance and communication to Originators and Managers in order to share best practices and resolve change issues and/or discrepancies.
• Ensure adherence to regulatory guidelines during change control processing.
• Update the master document list and maintain final word versions for revision purposes to maintain the integrity of the document revision.
• Ensuring procedures are followed and the most current revisions of processes and governing documents are in place.
• Scan, image, organize files and retrieve documents; physical and electronic.
• Lead the development and roll-out of document control tools, such as scanning hardware, computer software, etc.
• Support organization and storage solutions.
• Participate in on-site audits and provide necessary documentation.
• Support the Training Program by designing and developing training programs.
• Enter employee training, identify overdue training, implement training profile updates, schedule training as required, file training records both physically and electronically.
• Monitor the status of employee training and manage implementation of controlled documents when requirements are met.
• Perform various functions and special assignments to assist the Director of Quality in the administration of department functions.
• Perform other duties as assigned.

Required Skills/Abilities:

• Proven accuracy, reliability and completeness in job accomplishment.
• Skill in organization and prioritization, and attention to detail.
• Ability to handle multiple tasks simultaneously.
• Excellent verbal/written communication skills.
• Ability to adapt to changing organizational and operational needs; ability to lead others through change.
• Strong team player and leader with the ability to work across multiple functions and disciplines.
• Required to pass all pre-employment screens (including drug, background, and criminal Checks).

Education and Experience:

• High School Diploma or equivalent required.
• Associates or Bachelor’s degree in related field preferred.
• One (1) year experience in document control within an FDA regulated industry required.
• Familiarity with Good Manufacturing Practices and Good Documentation Practices.
• Working knowledge of HACCP.

Physical Requirements:

• Ability to sit, view a computer screen, and use your hands/fingers for six (6) to eight (8) hours.
• Occasionally (up to three hours) walk through the office and warehouse as needed.
• Occasionally (up to three hours) reach above/below should level, stoop, kneel or crouch.
• Ability to speak and hear (in person/phone) throughout the shift (up to eight hours)
• Good eye/hand coordination.
• Occasionally lift or carry up to 25 pounds

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• AD&D insurance
• Dental insurance
• Disability insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift

People with a criminal record are encouraged to apply

Experience:

• Document management: 1 year (Required)

Ability to Commute:

• Van Alstyne, TX 75495 (Required)

Ability to Relocate:

• Van Alstyne, TX 75495: Relocate before starting work (Preferred)

Work Location: In person