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Document Control Specialist
1 month ago
Document Control Specialist
At Minaris Regenerative Medicine our vision is creating future cell therapy miracles together. We are a leading global contract development and manufacturing organization dedicated to the advancement of cell and gene therapy products. We believe in the transformative potential of cell and gene therapies and we are shaping the future of medicine. We open doors in the regenerative medicine industry for those looking to transform medicine while continuously improving an innovative, growing company.
The DCS will be responsible for the management and maintenance of the electronic Document Management System (eDMS), consisting of document generation, control and compliance of electronic generated documents under the direction of the Document Control Manager. In this role the DCS is responsible for all Records Management activities; storage, retention and archival of original paper documents associated with Clinical Development, Technology Transfer and Clinical/Commercial Manufacturing. The DCS will support any client or regulatory inspections by providing the appropriate documentation based upon audit requests. The DCS will lead or co-lead cross-functional teams to coordinate and monitor Document Control and Records Management related activities. The DCS will also participate in various project teams or activities that align with the function’s strategic vision. The DCS will also be the primary backup for e-QMS System Administration
Essential Functions and Responsibilities
Below is the summary of the role responsibilities. This is not necessarily an exhaustive list of all responsibilities, duties, skills, efforts, requirements or working conditions associated with the role. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned with or without notice.
Receipt of incoming record(s) for Minaris locations.
Document record(s) receipt in record location database
Prepare record(s) for repository storage location
File record(s) in assigned storage location
Monitor record request inbox
Respond to incoming record withdrawal requests
Prepare requested record for distribution
Notify requestor record is available for distribution
Document record withdrawal in record location database
Follow up/reconciliation of distributed record(s)
Receipt of incoming logbook(s)/notebook(s)
Document logbook(s)/notebook(s) receipt in record location database
Prepare logbook(s)/notebook(s) for repository storage location
File logbook(s)/notebook(s) in assigned storage location
Record Management/Archival
Management of records retention program
Prepare/inventory documents, records and logbooks/notebooks for internal and offsite archival
DMS (Document Management System)
Train personnel for document authoring & reviewer/approver role within DMS
Perform administrator duties in DMS
Create/revise/manage document templates
Create/revise quality documents in DMS
Review documents in DMS for GDP compliance/template adherence
Manage publishing documents process in DMS to support business initiatives
Qualifications
5 years Records Management knowledge/experience (preferably with GxP Documents, SOPs, Protocols, Batch Records, Validation Documents etc.) Clinical/Research/Pharmaceutical experience a plus.
Technical writing experience within a scientific related environment a plus
Experience with e-DMS systems and e-QMS systems
Relevant IT skills (Word and Excel) (Visio, Microsoft Project a plus)
Competencies/Candidate Profile
Time management, organization/prioritization skills
Ability to multi-task in a fast-paced environment; deadline driven
Strong written and oral communication skills
Ability to think strategically (detail-oriented)
Effective problem-solving skills
Strong influencing skills and ability to work well in a cross-functional, matrixed environment is essential
Sound Decision making skills
Ability to effectively collaborate with peers and management
Supervisory Responsibility
This job has no supervisory responsibilities.
Quality Requirements (Required language – Do Not Edit)
Build Quality into all aspects of your work by maintaining compliance to all quality requirements.
Ensure compliance to all FDA and Worldwide Quality & Compliance regulations (As applicable to the job function).
Attend all required Quality & Compliance training at the specified interval.
Minimum Required Training
GXP training
SOP & WI training
E-QMS Training
Safety Training
New Employee Orientation Training
Working Environment
Must have the ability to work in a team-oriented environment and with clients
May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids and are expected to utilize universal precautions with all human specimens
Must be able to handle the standard/moderate noise of the manufacturing facility
This role operates within a professional office environment of a manufacturing operations plant. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets, and fax machines. Seating is mixed and includes open space seating, cubicle, and office space. The noise level is moderate.
Physical Requirements
The physical demands described here represent those that must be met by an employee to perform the essential functions of the job successfully.
This role is sedentary. An individual may occasionally exert up to 10 pounds of force or a negligible amount of force frequently to lift, carry, push, pull, or otherwise move objects. Sedentary entails sitting most of the time but may involve walking or standing for brief periods.
Must be capable of moving, sitting, stretching, stooping, reaching with hands and arms, and have vision sufficient to read materials.
Must be capable of using hands and fingers to operate a computer and other office productivity machinery such as copy machine, printer, and calculator.
Must have the ability to communicate information and ideas so others will understand. Must be able to exchange accurate information in person, and on the telephone.
The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading. An integral part of this position is preparation or inspection/review of documents.
Disclaimer
The above information in this description is intended to describe the general nature and level of work performed. It does not contain nor is it intended to be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. Duties, responsibilities, and activities may change at any time with or without notice.
Monday-Friday, Day Shift
