FLSA Status:  Non-Exempt

Summary:  As a Quality Assurance Team member, the QA Document Control Specialist assists with maintaining all elements within Tec Labs’ Quality Assurance Program to ensure compliance with Current Good Manufacturing Practices (CGMP) regulations, FDA, GMP, and any other regulatory requirements. This position is primarily responsible for change control management, training corrective and preventive action, quality incident reporting and supplier quality.  Distributes information related to quality and process improvement functions, possibly including but not limited to compliance to and/or documentation of quality management standards, such as 21 CFR Parts 210 & 211.

Duties and Responsibilities include the following. Other duties may be assigned.

  1. Coordinates the revision, review, and approval and obsoleting of SOPs and other GMP documents. Responsible for ensuring department managers perform scheduled reviews of documents and SOPs.
    1. Ensure adequate documentation, practices, and procedures are aligned with regulatory and current SOPs and CGMPs.
    2. Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
  2. Supports readiness of the facility for regulatory inspection(s). Assist the Senior Quality Assurance during regulatory inspections and internal company audits.
    1. Actively participates in internal audits, or any other outside audits, and inspections.
  3. Monitors and manages the ongoing revisions and change control of policies and procedures
    1. Review, edits, and approves change control and SOPs.
    2. Review, edits and approves new and revised master manufacturing records.
  4. Stays apprised of legal and regulatory changes and industry best practices regarding compliance and strive to implement continuous enhancements to the company’s compliance program accordingly.
  5. Supports Quality Assurance (QA) activities.
  6. Performs other related duties as assigned.

Required Competencies (Knowledge, skills, and experience)

  • Bachelor’s Degree in a life science with a minimum of 4 years of experience in a GMP regulated environment and experience with 21 CFR Parts 210 & 211.
  • In-depth knowledge and understanding of Quality Management System regulations and requirements, global quality standards and cGMPs relating to documentation, training and electronic systems, including electronic records and signatures (Master Control).
  • Strong authorship and ability to communicate effectively across the entire Tec Labs

organization on matters related to documentation and knowledge management systems.

  • Able to prepare written communications with clarity and accuracy.
  • Must be able to work independently with the ability to complete routine tasks with little or no supervision.
  • Able to respond to challenges and additional projects in an understanding, positive, and objective manner; adaptable to dynamic conditions, work practices, and project timelines.
  • Must be proficient in Microsoft Office (Excel, Word, PowerPoint, etc.)

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to stand; walk; use hands to fingers, handle or feel; reach with hands and arms; and talk or hear.  The employee is frequently required to sit; stoop, kneel, or crouch.