Technical Document Control Specialist

 

 

Job Title:   Technical Document Control Specialist

Department:  Regulatory Affairs and Quality

Reports To:    Senior Director Regulatory Affairs and QualityFLSA Status:    ExemptJob Summary:

Reporting to the Sr. Director of Regulatory Affairs and Quality, the Technical Document Specialist will lead worldwide Technical Document efforts in support of new product introduction in key markets and sustain a favorable compliance profile of marketed products through development, implementation and control of specifications, processes, systems and policies. 

 

Job Requirements: (Others may be assigned)

· Responsible for oversight, alignment and execution of technical documents with internal and external RA /QA partners and may include data related to projects preparing products for clinical trial development.  Documents such as:  master formulas, manufacturing process instructions, Finished Product Specifications, Packaging Specifications, Finished goods release testing, Stability testing, test methods development protocols and validation, process validation, lab and product support. 

· Submission of Establishment Licenses yearly renewal with all State, local and Federal requirements.

· Submission of Drug Wholesale License in all 50 States on as required basis.

· Work with New Product Development Teams (Product Development, Marketing, and Procurement) to support processing of new technical documentation and any changes to existing documentation.

· Ensure all related specifications are in place prior to first production for all new products.

· Participate on Technology Transfer Teams to ensure proper hand off of data and

· Accountable for Managing Document Control Systems and maintain status of current documents such as artwork world wide.

· Ensure all changes to specifications are properly documented and in place for all marketed products.

· Participate in development of protocols for bulk and filling line trials for all new products and changes to existing products to ensure the manufacturing site has executed trials and process changes in compliance.

· Develop new and update existing Standard Operating Procedures supporting Quality Systems.

· Execute and maintain training of personnel on new SOP’s and changes to existing SOP’s.

· Develop and implement Electronic document solutions to constantly improve sourcing and availability of documents.

· Execute and maintain documentation archives.

· Coordinate and lead support teams during FDA, State and Local Inspections.

 

Travel and Work Environment:

5% domestic travel. 

Office Environment with occasional high stress launch cycle pushes requiring extended hours to complete projects.  Work is 85% computer based.

 

 

 Education and/or Experience:Bachelor's Degree in a technical scientific discipline and or equivalent Quality Systems and Compliance experience with shop floor Rx, OTC and Cosmetic Manufacturing.

Special Skill Set:

· Must have excellent verbal and written communication skills, strong leadership skills and the ability to handle multiple high priority assignments.

· Quality Systems and Document Control focused self-starter team player.