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Job Title: : Quality Documentation Specialist

Duration: 2 Years contract

Location : Wilson / NC / 27893

Job Description:

+ This position is responsible for carrying out tasks and projects related to document control and document management for Wilson, NC (later referred to as BioNC) as required by current Good Manufacturing Practices (cGMP). These activities include the administration of the electronic document management system, preparation/submission of documents into and retrieval from archive, and the management of controlled documents through the review, approval, circulation and revision processes.

Responsibilities:

Specific tasks and job duties required include, at minimum:

+ Provide support and direction to all departments in respect of document control to ensure business, quality and compliance goals are met

+ Partners with other Departments to ensure that documentation programs are completed in an efficient manner

+ Perform tasks related to tasks related to the management of document control and records management in respect of SOPs and other GMP regulated documents

+ Receive and log documents submitted by site personnel for inclusion into the document control system

+ Review received documents for conformance to site systems in respect of format, numbering, etc.

+ Liaise with document owners in respect of approval schedules and implementation of new or revised documents

+ Provide feedback from document review to the document owners

Perform tasks related to administration of the Electronic Document Management System at the site.

+ Add new users to the system and assign privileges as directed by the QA Systems Manager

+ Set up review and approval routings for SOPs and other GMP regulated documents as directed by the QA Systems Manager

+ Track documents through the review and approval processes and advise relevant personnel accordingly.

+ Participate in upgrading activities of the system as appropriate.

+ Generate reports from the system as directed by the Quality Systems Manager

+ Develop and apply systems and procedures related to the Electronic Document management System at the site

+ Perform tasks related to the storage and archiving of documents related to BioNC including validation documents

+ Prepares and catalogues documents for archival

+ Coordinates with internal and external groups for the archival of documents

+ Manages document retrieval from archive storage as requested.

+ Regulates access to on-site document storage

+ Audits internal and external document storage/archive systems

+ Partner with BioNC Learning & Development department in the provision of training in Good Documentation Practice (GDocP) and GMP to site personnel as directed by the Quality Systems Manager

+ Assist BioNC Learning & Development department the development and maintenance of training materials for provision of GDocP and GMP training to site personnel

+ Coordinate periodic review of all GMP documentation with site personnel

+ Manage the record retention program as it applies to global and local requirements

+ Support in inspection readiness at the as documentation and records management SME

+ Serve as a delegate for Quality Systems Manager, when appropriate

+ Perform related duties as assigned by supervisor

+ Maintain compliance with all company policies and procedures

Experience:

+ minimum of 3 years of experience in document management or related role within the biological and/or pharmaceutical industry

+ Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals and ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position

+ Excellent computer proficiency electronic document management system (i.e. Veeva, Master Control, Documentum, etc.)

+ Excellent communication and interpersonal skills with the ability to effectively collaborate with cross-functional teams

+ Proven ability to manage multiple priorities and work independently with minimal supervision

+ Detail-oriented mindset with a keen eye for identifying opportunities for process improvements

+ Ability to work in a team environment and interact with all levels of the organization

+ Ability to build and nurture strong and positive relationships

+ An unquestionable level of integrity and commitment to operate ethically and within the boundaries of regulatory requirements

+ Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.

Skills:

+ Must have GxP Documentation experience

+ The documentation is used published for trainings

+ Must have experience with electronic document systems (Veeva Vault)

+ Knowledge of life cycle of documents

+ Quality Systems experience, the system itself and the documentation process

+ Experience with CAPA, highly desired

+ Change Control, highly desired

+ Must have at least 3 years of experience

+ Pharma background, helpful

+ Must have knowledge of FDA / EMEA regulatory documentation

Education:

+ Bachelor’s degree in a scientific, engineering, or technical discipline is required

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com (http://www.ustechsolutionsinc.com/) .

US Tech Solutions is an Equal Opportunity Employer.All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Recruiter Details:

Name: **I.Prudvi kumar**

Email: **[email protected]**

Internal Id: **25-45012**