Document Systems Administrator

Who we are?

We are a French pharmaceutical industrial group, recognized for making affordable healthcare products that improve and simplify patients’ lives to as many people as possible.

With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees.

Since 2013, our site Unither Manufacturing LLC. based in Rochester (NY), specializes in the manufacture of Blow-Fill-Seal, Liquid Stick-Packs, Pharmaceutical bottles, Tablets and Capsules. It has more than 280 employees.

Your role

Reporting to the Quality Systems Manager,

The Document System Administrator position provides support for the cGMP documentation activities for the cross functional departments on the site. This position has the responsibility to support document control functions in the pharmaceutical environment including both electronic and paper-based systems.

The Document Systems Administrator acts as the key point of contact for TrackWise and /or EnnovDoc administration. The administrative role includes monitoring the systems to ensure they work in line with GMP standards and business needs, addressing any end-user issues as well as training requirements.

This position will assist in ensuring compliance to the regulatory requirement and will interact with all areas within the company to ensure the coordination and publishing of documents are complete in a timely manner with a high degree of accuracy.

DUTIES / RESPONSIBILITIES:

Administers Compliant Electronic Document Management Systems (EDMS)

Performs administrative functions of the TrackWise and/or EnnovDoc System including creation, revision, proofreading, signature, implementation, and cancellation of quality system documents/records

Acts as secondary administrator of the EDMS and/or TrackWise system in the absence of the primary administrator

Create/revise Quality systems procedures related to the EDMS system/TrackWise

Initiate and investigate any deviations related to the EDMS and/or TrackWise and ensure on-time completion of all investigations and associated CAPAs

Continuously improve the processes related to the EDMS systems and/or TrackWise, proposing potential improvements

Perform global administration activities including account creation, system configuration modifications, software upgrade activities, periodic reviews based on appropriate change controls/project milestones.

Perform training of all new users and ensure user maintain appropriate level of compliance within the systems.

Monitor regulatory activity to maintain compliance in the EDMS and the physical storage of records.

Processes Controlled GMP documents

Effectively manages Controlled Documents to ensure consistency, accuracy, and traceability.

Manage all site GMP logbooks (creation, issuance, archiving)

Audit all site logbooks for adherence to GMP and company procedures

Issue documents and GMP records to appropriate personnel by requested date

Coordinates 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.

Monitor the periodic document review process, routine reporting of KPI’s, monitoring of the due dates, and follow-up to ensure on time completion.

Maintain site procedure books, both paper and electronic.

Types/formats cGMP documents which may include, but not limited to, Standard Operating Procedures (SOP’s), forms, laboratory worksheets, protocols, reports, batch cards

Write or revise company Standard Operating Procedures, Reports, and/or Protocols or any site documentation as needed.

Assist in the updating of documents by acting as the co-author within the EDMS system, as needed, to support all departments

Assist with documentation needs during customer and regulatory agency audit

Provides required documentation for yearly Annual Reviews

Manages all Documentation Room Functions

Define document management policies and procedures to facilitate efficient storage and retrieval when necessary, and security to prevent loss or adulteration (electronic and paper).

Maintain tracking system for records that have been requested, checked-out, and returned.

Retrieve electronic or paper records for distribution to users, collecting and returning to repository as needed.

File/Assist with filling of all documentation housed in the Documentation Room

Identify opportunities for improvements in accuracy and efficiency within the Documentation Group or within the document control processes involving other departments. Lead improvement projects that may have cross-departmental team members and shared benefits.

Manage communication with outside vendors utilized for printing or other services used by the Documentation Group.

Manage inventory of documentation resources, assets, and supplies; including paper stock for manufacturing (batch) documentation.

SPECIFIC SKILLS:

Professional communication skills with customers, leadership, and peers – communication via telephone, written form, e-mail, and in person are all required.

Attention to detail: Observing and interpreting document system data and patterns

Compiling, coding, categorizing, and other types of processing documentation

Teaching and training others

Excellent organizational skills

Innovation and thinking creatively to solve problems

Time management

Inventory management

Computer Skills:

Basic Outlook skills as evidenced by creating and sending messages, working with address books, message handling, creating and using personal folders, scheduling appointments, working with meeting requests and managing tasks.

Intermediate Microsoft Word skills as evidenced by the ability to produce basic business letters and simple tables and charts; as well as check spelling, set tabs, change page orientation, sort, save, open and organize electronic files; as well as create moderately complex documents containing tables and graphs, and ability to mail merge documents, apply page setup functions (margins, page numbers, footers, headers), create an index and/or table of contents, use search & replace, print labels and envelopes.

Basic Excel skills as evidenced by the ability to use workbooks, create simple formulas, insert and delete data, create and edit charts, filter and sort lists, and format data.

Intermediate Microsoft Access skills as evidenced by the ability to open an existing database and table, print an existing table, move from record to record, copy and paste data; add, find and edit records; select a record, delete a record, sort data, create and apply filters, create a query, and print reports; as well as the ability to create a form, add form headers and footers, change page layouts, create reports from a table, and create mailing labels.

Basic PowerPoint skills as evidenced by the ability to create and save a presentation, add titles, edit and delete slides, reordering slides, applying slide masters, checking spelling, and adding clip art.

Basic Microsoft Project skills as evidenced by the ability to assign resources and their work schedules to tasks, effectively use the different views, reports, and drawing tools, resolve time and resource conflicts, sort and filter information effectively and work with subtasks in an outline form, link tasks effectively and work with time constraints.

Basic Visio skills as evidenced by the ability to design and manage basic diagrams, workflows and flowcharts.

Your profile

REQUIRED EDUCATION:

AAS degree or BS degree in Life Sciences, Communications, Business Administration, Technical Writing, or related field.

QUALIFICATIONS/EXPERIENCE:

1-3 years’ experience working in a production, pharmaceutical or regulated environment.

Computer proficiency with working knowledge of EnnovDoc and/or TrackWise preferred.

Ability to work autonomously using established procedures, seeking guidance where needed.

Self-motivated and demonstrated ability to learn and work in a fast-paces environment where multiple concurrent projects must be completed in a timely manner.

Experience in audits and regulatory inspections a plus

Compensation range

27.00 - 32.00 USD

*The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Learn more about us:

We are a dynamic company driven by a spirit of victory and are therefore pursuing strong growth while maintaining a close relationship with our customers and employees.

Our culture is based on 5 values: Respect, Responsibility, Trust, Courage and Innovation. We are committed to bringing these values to life with our employees by granting them a high degree of autonomy in the exercise of their profession and by encouraging their initiatives.

We are committed to providing them with working conditions and atmosphere that is conducive to their development and the expression of their potential.

We propose you to integrate a site that values the meaning of work and that entrusts our employees with a high level of responsibility.

Join us and make a difference!