Basic Function and Responsibility:|
This position is responsible for the day to day operation of the
GMP and Non-GMP Document Control function managing and maintaining the flow of both electronic
and hard-copied controlled documents, department files and resource materials. Incumbent is
responsible for change incorporation, master filing and GMP document activities and change
administration requirements for product documentation. In addition, performs process improvements
within the Document Control Area.
Manage Change Control through automated tracking system (TrackWise or other) as required by cGMPs. Maintains change/revision history.
Administration and Maintenance of the Quality System documents - Master Records, SOP, Annual Product Review, Area Reference copies, etc. Oversees Periodic Review documentation, filing and archiving activities.
Administration and Maintenance of the company documents - financial records, etc. Oversees Periodic Review documentation, filing and archiving activities.
Issuance of lot numbered documents and forms for manufacturing, quality control and other departments as needed.
Customer Service Activities -departmental copy requests, internal customer inquiries, expedition of departmental copy requests, support departmental research / investigation activities.
Develop and Manage Off-Site Storage Program.
Direct the Document Control personnel activities including job assignment, training, performance evaluation and compensation review.
Ensure new employees receive cGMP training upon hire or soon after and facilitate on-going cGMP training for current employees.
Write or revise SOPs to control critical systems and assure conformance to cGMPs.
Perform or delegate other duties or special projects as assigned
Requires strong computer skills, Microsoft Office Applications (Access, Excel and Word).
Must be detailed oriented, be able to follow detailed instructions, possess excellent time management skills, be well organized, a self starter and display a professional demeanor with a high focus on quality, compliance, and responsibilities.
Ability to follow through and consistently demonstrate that all primary job duties and responsibilities are current and up to date; ability to closely monitor and communicate progress on daily tasks and responsibilities to Management.
Must be able to work as a team member, maintaining day to day activities while being responsive to changing priorities.
Knowledge of Good Manufacturing Practices required.
Must be able to work a consistent schedule to satisfy the responsibilities of the job.
Knowledge of electronic document systems.
Prior experience in management is required.
Four-year degree in a technical field, preferably in Chemistry or Microbiology, with 5 years of experience in Quality in the medical device or pharmaceutical industry.
Please provide salary requirements to be considered for this position.