Document Specialist

Description:

The Contract Quality Systems Documentation Specialist is responsible for assisting in the management and administration of the Document Control systems to ensure compliance to applicable internal procedures, cGMPs, and regulatory requirements. The position is responsible for document processing, maintenance of documents/ records, issuance of logbooks, notebooks and protocols, and maintenance of various indices/ logs.

Process various site documents using computer-based systems, including, but not limited to, Standard Operation Procedures (SOPs), Standard Certification Methods (SCMs), Standard Testing Methods (STMs), Specifications, and Batch Production Records.

Catalog, scan, maintain, archive/file and retrieve various site documents/ records, including, but not limited to, SOPs, Batch Records, Datasheets, Logbooks, Notebooks, Regulatory Documents, and Validation Protocols.

Update various information indices (Excel, Access, etc.) as necessary.

Prepare logbooks and issue logbooks and notebooks for use across the site.

Additional Skills & Qualifications:

Associates degree preferred, High School Diploma or equivalent is required.

2 or more years of documentation experience in a cGMP facility REQUIRED

Experience with computer data entry required. Must be proficient with Microsoft Office, including Word, Excel, Access, Visio, Outlook, and Power Point.

Ability to accurately type 45 words per minute.

About 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.