Lead Documentation Specialist - SLC East

The opportunity

This position provides Quality Documentation support for the cross-functional departments. This position has the responsibility to support Document Control functions in a pharmaceutical environment.

This person will assist in ensuring compliance with regulatory requirements and will interact with all areas within the company to ensure that change coordination and publishing of documents are completed in a timely manner with a high degree of accuracy.

How you’ll spend your day

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary.

Any non-essential functions are assumed to be included in other related duties or assignments.

• Responsible for independently performing day-to-day tasks that occur in a Document Control Function (typing, filing, research, etc.).
• Responsible for assisting in coordination of the review and revision of controlled documents (master batch records, procedures, specifications, test methods and forms) to ensure consistency in format and presentation of content for all documents.
• Responsible for helping to ensure adequate and compliant document change control practices.
• Responsible for assisting with the organization and maintenance of files for submitted documents, all master documents and document history as needed.
• Responsible for issuing documents, and GxP records to appropriate personnel, in a timely manner.
• Responsible for effectively interacting with other functional groups (e.g., Production, external regulatory affairs, etc.)
• Responsible for assisting in the coordination of activities related to the implementation and maintenance of an EDMS (electronic document management system).
• Responsible for assisting in writing and / or revising departmental Standard Operating Procedures as needed.
• Responsible for effectively addressing CAPA and deviation resolutions as needed.
• Responsible for generating reports from EDMS and other software applications.
• Responsible for supporting regulatory agency audits with ability to field and respond to audit requests (backroom lead).
• Responsible for representing Document Control on project / product teams as assigned.
• Responsible for training and providing guidance to lower level employees as needed.
• Responsible for completing training requirements and maintaining compliance with all assignments.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP’s) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Your experience and qualifications

Any equivalent combination of education, training and / or experience that fulfills the requirements of the position will be considered.

Education / Certification / Experience :

• Requires a high school diploma / GED or equivalent, with 4 or more year’s relevant, progressive experience in pharmaceutical or device manufacturing environment.
• Would prefer an associate degree with a minimum of 3 years’ experience, progressive experience in pharmaceutical or device manufacturing environment.
• Working knowledge of GMP regulations required.

Skills / Knowledge / Abilities :

• Computer proficiency with emergent working knowledge of MS Office products, Learning Management Systems (LMS), EDMS.
• Understanding of ERP systems, as well as Quality systems such as Trackwise preferred.
• Ability to handle and move between multiple tasks.
• Ability to train other personnel on new assignments and larger groups on new systems and / or processes.
• Interact positively and collaborate with co-workers, management and external partners.
• Self-directed with ability to organize and prioritize work.
• Communicate effectively with excellent written and oral communication skills.

Problem Solving :

• Works on problems of moderate scope where evaluation of contributing factors requires analysis of situation or data.
• Exercises judgment within broadly defined practices and policies and selects methods and techniques for obtaining solutions.
• Selects methods, techniques, and evaluation criteria for obtaining results.
• Acts independently and proactively to recommend methods and procedures for problem resolution.

Enjoy a more rewarding choice

We offer a competitive benefits package including Medical, Dental, Vision, and Prescription coverage starting on the first day.

We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance.