Ursitti Enterprises LLC
Document Control Specialist - 1837468
Ursitti Enterprises LLC, Portage, Indiana, United States, 46368
Job Description
Job Description
1st Shift Document Control Specialist Needed in Portage! $25-$35 Hour!
Job Summary: The Document Control Specialist coordinates and maintains the company's Document Control and Training system, strictly follows established company policies and procedures to ensure compliance with pharmaceutical industry regulations and standards, as well as maintaining record and document control, data integrity, and training associated with automated and manual/paper-based processes. The Document Control Specialist will report to the Program Manager, Training and Document Control
Responsibilities: • Overall coordination of controlled documentation within the company • Performs the Document Control function within the Master Control system: Facilitates and maintains the flow of documents and training tasks through Master Control. • Manages document lifecycle and approval process including, but not limited to Author, revise, route, review, approve, release, and distribute documents, both in the paper and electronic systems • Works with cross-functional teams to ensure documents are made effective in a timely manner. • Ensures proper formatting of all controlled documents according to SOPs in bath pager and electronic systems. • Trains and serves as backup System Administrator for Master Control • Participate in implementation of new electronic systems company-wide as it relates to training, document storage, retention, and issuance. • Investigates and responds to corrective actions related to Document Control and Training • Acts as primary point of contact for day-to-day Master Control end user issues and requests. • Acts as Single Point of Contact for all controlled document requests. • Creates, tracks and trends data from F8S and Document Control, working closely with other functions to identity, monitor, and influence process improvements. • Provides support for the training function as primary paint of contact tor creation, revision, and deactivation of new user training, jab cades, courses, training materials, and exams, • Works with functional area managers to author, assign, and deliver training. • Assists with New Hire Onboarding Training • Trains employees on use and access at Master Control • Manages and maintains paper End electronic training files. • Creates and maintains Master Control reports. • Manages Periodic Reviews and Revisions of documents in Master Control • Manages and maintains the Document Control Center (physical record archives) including organization, filing, and retrieval of documents, as needed. • Creates and maintains a record retention schedule tar both paper and electronic systems per applicable regulations. • Physical filing of pager records submitted for retention. • Scans appropriate paper document: submitted far retention and stores Electronic scanned files. • Adheres to the Corporate and Company record retention policy for documents stored within the Document Contral archive room, Including record cleanout and destruction. • Manages relationship with third-party tor off-site documentation retention and requests tar documents tram third-party. • Ensures timely distribution, retrieval, and reconciliation of required documents. • Issues controlled paper documents Including but not to Production Satch Records, Production Labels, Logbooks • Assists in supporting internal and external audits, coordinating activities [n backroom and ensuring timely tile retrieval and response to document and training requests. • Ability to manage complex programs in a dynamic environment interacting within various levels of management. • Other duties within Document Control, Training and Quality as necessary.
Qualifications: • Minimum 5-year of administrative assistant experience in a regulated environment preferred. • High School Diploma required, associate degree or college coursework preferred. • Experience with Electronic Document Management required (Master Control is highly desirable) • Excellent Microsoft Ward skills, including performing complex formatting, outlining, reviewing, track changes and ability to be self-directed in performing these tasks. • Strong experience with Microsoft Office Products including Ward, Excel, PowerPoint, and Teams • Knowledge of GxP regulations preferred. • Previous experience and knowledge of GxP regulations, with the ability to author, understand and follow Standard Operating Procedures in a regulated environment is preferred. • Ability to work in a cross-functional, team-oriented environment. • Proactive, self-directed individual with strong organizational skills and outstanding attention to detail with the ability to prioritize, multitask and work with a high degree of accuracy and recall. • Possess a positive attitude, strong interpersonal skills, and a high level of motivation. • Ability to communicate effectively, both orally and in writing
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended as an exhaustive list of all responsibilities, duties, and skills required, the client reserves the right to make changes to the job description whenever necessary.
The selected candidate will be required to complete a drug test and background check prior to employment commencing,
This organization provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Job Description
1st Shift Document Control Specialist Needed in Portage! $25-$35 Hour!
Job Summary: The Document Control Specialist coordinates and maintains the company's Document Control and Training system, strictly follows established company policies and procedures to ensure compliance with pharmaceutical industry regulations and standards, as well as maintaining record and document control, data integrity, and training associated with automated and manual/paper-based processes. The Document Control Specialist will report to the Program Manager, Training and Document Control
Responsibilities: • Overall coordination of controlled documentation within the company • Performs the Document Control function within the Master Control system: Facilitates and maintains the flow of documents and training tasks through Master Control. • Manages document lifecycle and approval process including, but not limited to Author, revise, route, review, approve, release, and distribute documents, both in the paper and electronic systems • Works with cross-functional teams to ensure documents are made effective in a timely manner. • Ensures proper formatting of all controlled documents according to SOPs in bath pager and electronic systems. • Trains and serves as backup System Administrator for Master Control • Participate in implementation of new electronic systems company-wide as it relates to training, document storage, retention, and issuance. • Investigates and responds to corrective actions related to Document Control and Training • Acts as primary point of contact for day-to-day Master Control end user issues and requests. • Acts as Single Point of Contact for all controlled document requests. • Creates, tracks and trends data from F8S and Document Control, working closely with other functions to identity, monitor, and influence process improvements. • Provides support for the training function as primary paint of contact tor creation, revision, and deactivation of new user training, jab cades, courses, training materials, and exams, • Works with functional area managers to author, assign, and deliver training. • Assists with New Hire Onboarding Training • Trains employees on use and access at Master Control • Manages and maintains paper End electronic training files. • Creates and maintains Master Control reports. • Manages Periodic Reviews and Revisions of documents in Master Control • Manages and maintains the Document Control Center (physical record archives) including organization, filing, and retrieval of documents, as needed. • Creates and maintains a record retention schedule tar both paper and electronic systems per applicable regulations. • Physical filing of pager records submitted for retention. • Scans appropriate paper document: submitted far retention and stores Electronic scanned files. • Adheres to the Corporate and Company record retention policy for documents stored within the Document Contral archive room, Including record cleanout and destruction. • Manages relationship with third-party tor off-site documentation retention and requests tar documents tram third-party. • Ensures timely distribution, retrieval, and reconciliation of required documents. • Issues controlled paper documents Including but not to Production Satch Records, Production Labels, Logbooks • Assists in supporting internal and external audits, coordinating activities [n backroom and ensuring timely tile retrieval and response to document and training requests. • Ability to manage complex programs in a dynamic environment interacting within various levels of management. • Other duties within Document Control, Training and Quality as necessary.
Qualifications: • Minimum 5-year of administrative assistant experience in a regulated environment preferred. • High School Diploma required, associate degree or college coursework preferred. • Experience with Electronic Document Management required (Master Control is highly desirable) • Excellent Microsoft Ward skills, including performing complex formatting, outlining, reviewing, track changes and ability to be self-directed in performing these tasks. • Strong experience with Microsoft Office Products including Ward, Excel, PowerPoint, and Teams • Knowledge of GxP regulations preferred. • Previous experience and knowledge of GxP regulations, with the ability to author, understand and follow Standard Operating Procedures in a regulated environment is preferred. • Ability to work in a cross-functional, team-oriented environment. • Proactive, self-directed individual with strong organizational skills and outstanding attention to detail with the ability to prioritize, multitask and work with a high degree of accuracy and recall. • Possess a positive attitude, strong interpersonal skills, and a high level of motivation. • Ability to communicate effectively, both orally and in writing
The above statements are intended to describe the general nature and level of the work being performed by colleagues assigned to this position. This is not intended as an exhaustive list of all responsibilities, duties, and skills required, the client reserves the right to make changes to the job description whenever necessary.
The selected candidate will be required to complete a drug test and background check prior to employment commencing,
This organization provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.