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Document Control/Labeling Supervisor

1 month ago

Garland, United States Theragenics Full time

PURPOSE OF JOB

The Document Control Supervisor is responsible for overseeing the activities of Documentation Associates/Clerks, adherence to specifications/ quality procedures, and meeting strict quality and compliance standards. This position is also responsible for maintaining the Document Control System in compliance with ISO/QSR, CGMP requirements, and approved procedures. This position will update master documents to reflect approved changes, update master indexes and files, distribute updated documents, archive old revisions, and create and file batch records.

RESPONSIBILITIES

Hire, train, or coordinate the training of document control personnel. Schedule and direct the work of document control personnel. Develop document control procedures and analyze and present data for management. Conduct performance reviews at required frequencies. Oversee document change order process, ensuring ECNs are processed in compliance with written procedures. Work with customers to establish requirements for new and revised product labeling and maintains proper communication Issue batch record documents and file/archive completed batch records. Prepare key indicator charts of performance goals, actual results, and trend analyses for document control & labeling processes. Assign duties to Document Control/label department personnel. Provide a guidance role to R&D, Engineering, and Manufacturing personnel for the development of all new product documentation being transferred from Development into Operations. Provide suggestions on improvement of Quality procedures without sacrificing efficiency or compliance with regulatory requirements.

REQUIREMENTS

EDUCATION

:

Bachelor of Science Degree preferred. EXPERIENCE

:

Minimum 1-3 years related experience in QA documentation, technicalwriting, and project management, or an equivalent combination of education, training, and experience. Microsoft Office knowledge(Word, Excel, PowerPoint) is a requirement. Familiar with MRP systems preferred. POSITION SKILLS

:

Must have MS Office mastery, experience with MS Project, ability to establish timelines and critical paths. Must be familiar with Galt Products and Systems. Familiar with QSR/ISO regulations and/or proven ability to work in a regulated environment according to written procedures. Excellent verbal and written communication skills. Must work independently and be able to prioritize numerous duties. Proven ability to use MS Word, Excel, and databases to facilitate a satisfactory documentation program. Must be able to get along well with all levels of employees. Must work quickly and efficiently with detail and accuracy Ability to read and interpret documents such as safety rules, and operating and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups, management, or employees of the organization. Ability to analyze data and assess risk based on objective evidence. Basic mathematical ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to apply common sense understanding to carry out instructions furnished in written, oral, diagram, databases, charts, and/or schedule form. Ability to deal with problems involving several concrete variables in standardized situations. Ability to deal with problems involving several concrete variables in standardized situations. WORK ENVIRONMENT Office work, with occasional excursions to the work floor as needed to ensure the project is executed on time. The incumbent will work in an office environment with moderate to low noise.

CONFIDENTIALITY This position has access to or may be exposed to confidential and propriety Company information. Therefore, a high level of confidentially must be maintained at all times with any Company information.

PHYSICAL DEMANDS The incumbent will sit, walk, stand; use hands to finger, handle, or feel; and reach with hands and arms. Lifts, carries, or otherwise moves and positions objects weighing up to 25 pounds. Will use close vision (clear vision at 20 inches or less); color vision (ability to identify and distinguish colors); and ability to adjust focus (ability to adjust the eye to bring an object into sharp focus).

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