Description:The Document Control Specialist coordinates and maintains the company's Document Control and Training System in the Quality group. Strictly follows Pharmaceutical industry guidelines and regulations and standards, as well as maintaining record and document control, data integrity, and training associated with automated and manual/paper-based processes.
Overall coordination of controlled documentation for the company
Ensure proper formatting of all controlled documents according to SOPs in both paper and electronic systems
Act as point of contact for all controlled document requests
Creates, tracks, and tends data from FBS and document control, working closely with other functions to influence process improvements
Provides support for the training function as primary point of contact for creation, revision, and deactivation of new user training, job codes, courses, training materials, and exams
Assist in New Hire Onboarding Training
Trains new hires on Mastercontrol system
Manages periodic reviews and revisions of documents in Mastercontrol
Managers and maintains the Document control Center (pysical record archives), including organization, filing, and retrieval of documents as needed
Physical filling of all documents submitted for retention
Stores electronic scanned filesIssues controlled paper documents including production batch records, production labels, and logbooks
Quality Assurance assistance as needed
Author, revise, route, review, approve, release, and distribute documents both paper and in the electronic system
Additional Skills & Qualifications:
HS Diploma Required; Associate's Degree or college coursework preferred in technical field (sciences or business admin, etc.)
Experience with Electronic Document Management required
Excellent Microsoft Word Skills, performing complex formatting, outlining, reviewing, track changes (change control), and ability to be self directed
Needs experience with Microsoft Teams and Excel
Knowledge of GxP regulations or GMP regulations
Understanding of SOPs
Ability to work independently and in team environment
Preferred= 3-5 years experience and Pharma experience
Batch Record
Quality Systems
Document Control
Mastercontrol
Experience Level:Intermediate LevelAbout Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.