Maintain the document management system as required including management of templates, allocation of document numbers and review of draft documents.
Perform all routine activities associated with the document change management system.
Support the revision and creation of GMP documentation through the document change process. This includes, but is not limited to, performing routing, document processing, and formatting of documents.
Perform all routine activities associated with manufacturing batch record issuance and reconciliation as well as creation, issuance and reconciliation of worksheets and logbooks which will require work inside classified manufacturing areas.
Perform all routine activities associated with laboratory documentation issuance and reconciliation as well as creation, issuance and reconciliation of worksheets and logbooks.
Assist with the records management program, including interim and archival activities as well as facilitate shipments to Iron Mountain.
Assist in the management and retention of documentation in accordance with records retention schedules in conjunction with legal hold notices
Perform document storage room activities such as filing, organization, barcoding in RMS and escorting personnel into the room.
Quals--
Minimum of 6 months experience with computer systems and documentation. This position requires demonstration of excellent organizational skills and attention to detail in a fast-paced environment. Personnel must demonstrate flexibility and capability of multitasking, as well as demonstrate excellent oral and written communication skills and excellent computer competence. Effective interaction with all contacts is required. Personnel must also exercise sound judgment in assuring compliance with Regulations. Self-directed with ability to take initiative and follow through to completion on commitments. Ability to create effective change in a team based collaborative environment.
EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans. •
Last updated on Nov 17, 2023