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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. Support Regulatory Affairs (US and Canada) by assisting in gathering information for submissions and annual reports. Ensure daily tasks are completed in a timely manner with strict attention to detail, and in accordance with applicable SOPs and cGMPs. Assist with audits (preparation, set-up, breakdown, retrieval of requested documents). Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP’s.Ensure maintenance of the department, premises, and equipment.
Additional Skills & Qualifications:
Associates degree preferred, High School Diploma or equivalent is required.1 or more years of documentation experience in a cGMP facility or in the medical transcription field is required. Office administration experience will also be considered.Experience with computer data entry required. Must be proficient with Microsoft Office, including Word, Excel, Access, Visio, Outlook, and Power Point. Willing to work occasional overtime and weekends as the business need dictates.Ability to work well both independently and in a team atmosphere.Demonstrated ability to closely adhere to all instructions, cGMP's, SOP's, policies and procedures required.Ability to accurately type 45 words per minute.Strong grammatical and document layout/design/formatting skills are mandatory.Strong organization skills are essential.Good communication skills.Strong organization and time management skills.
Experience Level:
Entry Level
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 actalentaccommodation@actalentservices.com for other accommodation options.
