Signed in as:

filler@godaddy.com

QA Document controller

Job Description:

 Assists with the management and follow-up of the Quality Assurance System and/or Product to guarantee the compliance with IBA certifications and Quality agreements. This includes but is not limited to:

  • Control of distribution of released documents.
  • Securely filing hard copy originals, superseded hard copy originals and supporting documents.
  • Act as electronic database administrator and provide support as needed for the database.
  • Control electronic database uploads of items as required.
  • Ensure that all product review, CAPA, OOS, Deviation, and Change Control documentation is filed as applicable.
  • Control the filing of all supporting documents (including but not limited to specifications, labels, MSDS, USP chapters, FDA references and FDA applications)
  • Ensure that the corporate QA document file is updated.
  • Minute all QA related meetings, coordinate attendee sign off as required and file.
  • Coordinate the collection and distribution of consultant work orders and invoices.
  • Assist purchasing to establish an approved supplier list.
  • Assist as required with all QA activities.


Qualifications:   

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Have Good knowledge of cGDP and cGMP
  • Ability to multi-task.
  • Ability to train all levels of personnel.


Education and/or Experience: 

College courses or higher is required. Experience in document management is preferred. Ability to read, write and speak English.


Language Skills: 

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.


Mathematical Skills: 

Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.


Reasoning Ability:

Ability to define problems, collect data, establish facts and draw valid conclusions. 


Computer Skills: 

Windows 98 or above. Proficient in all MS Office applications (Word, Excel, PowerPoint, Access and Outlook), Internet Experience. 


Behavioural Characteristics: 

Strong interpersonal communication and presentation skills. Facilitator. Decision maker. Interact with all levels of personnel. Motivator. Ability to multi-task. Quick learner. Team attitude.


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. Ability to remain seated for extended periods of time. Ability to use hands to finger, handle, or feel in using office equipment, including the computer system for extended periods of time. Ability to talk and hear to conduct frequent phone correspondence. Close vision and focus capabilities to view computer screen, Company documents, and correspondence.


Work Environment: 

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

There are no specific conditions affecting performance of this job. The noise level would be considered moderate for a business office with computers, printers, copiers, and light traffic. The position will often require more than forty hours of work per week. Individuals in this position may be exposed to radiation; however, radiation safety training and monitoring is required.


Additional Information: 

Clean driving record and ability to travel to all facilities and trade shows as necessary. Strong interpersonal skills for interacting with site personnel, internal and external vendors required.  Ability to problem-solve and handle issues. Travel is minimal, as required for training or business functions.

We offer a competitive compensation & benefits package. Join a company on the move!

Must be authorized to work in the U.S. Please send your CV to HR@spectronrx.com.

image4