Job Title: Quality Documentation Specialist
Location: 5100 Corporate Pkwy, Wilson, NC 27893
Duration: 24 months contract
Notes from HM:
Onsite 100% of the time in Wilson, NC
Must have a Bachelor’s degree
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
Essential Job Duties and Responsibilities:
This position is responsible for carrying out tasks and projects related to document control and document management for Wilson, NC 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.
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
Minimum Qualifications:
Bachelor’s degree in a scientific, engineering, or technical discipline is required
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.
Job Type: Contract
Pay: $30.00 - $33.00 per hour
Expected hours: 40 per week

Education:

• Bachelor’s (Required)

Experience:

• Documentation: 3 years (Required)
• Quality Documentation: 2 years (Required)
• GMP: 2 years (Required)

Work Location: In perso

Please refer the Job description for details