What are the responsibilities and job description for the Documentation Control Specialist position at Actalent?
Description:
• Ensure that Quality Assurance (QA) functions are in compliance with all required Current Good Manufacturing Practice (cGMP) regulations • Assist in internal and external audits as necessary • Maintain compliant electronic archive for quality/batch records (scanning, filing) as required • Assist with biannual review of Standard Operating Procedure • Assist in monitoring and maintaining the Quality Management System (QMS) with activities such as facilitating batch record review/release, as well as assisting in closure of Change Controls, SOP revisions, Non-Conformance and Corrective Action and Preventive Action (CAPA) investigations • Communicate with different departments and members of leadership in regard to findings • Maintain a high level of cGMP compliance and stay abreast of industry and regulatory compliance trends and requirements • Ensure activities are performed in accordance with federal, state, and internal SOP guidelines • Review and analyze appropriate test results for the release of bulk and final product Skills and Qualifications: • Minimum High School Diploma and 4 years in a Manufacturing environment, required • Experience in Document Control, Batch Record review or relevant Quality/Compliance function, preferred • Excellent time management skills to coordinate multiple projects and adhere to tight timelines • Proficient with Microsoft office software • Strong organizational skills with the ability to work with a high degree of accuracy • Excellent customer service to internal and external users of documents • Familiarity with Quality Management System or other regulated environment • Knowledge and adherence to industry regulations and company standards • Excellent interpersonal, verbal, and written communication skills • Proven ability to take initiative and deliver results through effective problem-solving and critical thinking • Experience scanning paper documents and managing digital file
Skills:
Document control, Quality assurance, Documentation quality assurance
Top Skills Details:
Document control,Quality assurance,Documentation quality assurance
Experience Level:
Intermediate 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.