Documentation Clerk jobs in Danbury, CT

The specialist is responsible for supporting the Quality Management System by ensuring compliance with established procedures and quality/business requirements. The specialist is responsible for supporting the Business Management System by ensuring Production is supplied with accurate labels and documentation required to fill products in a timely fashion.

Responsibilities:

• Deviations - Process company-wide deviations by logging, following up, seeking management approval, following up on any corrective actions needed, and closing out. Participate in root cause analysis and corrective action development as needed.
• Change Controls - Maintain the change control process by processing document changes, processing and auditing new product set ups and processing and auditing private & customer labels.
• Document Management – Batch Records, Labels, Supporting Documentation. Print and audit batch records, labels and other required documentation in accordance with production schedule, tank list and established procedures. . Control and issue batch records and labels in accordance with established procedures. Support Production needs by printing additional labels/documents and reconciling additional labels. Proactively communicate label stock inventory concerns to DMS Lead and Supply Chain.
• Document Archive/Management - Ensure controlled documents are properly filed, archived and maintained in accordance with ISO and GMP requirements. Includes Quality Control Product Files, Batch Production Record packets and other quality documents. Retrieve archived documentation in a timely fashion.
• Printer Hardware Maintenance - Be familiar with label printers and understand the basic mechanisms of the hardware. Maintain the printers through regular cleanings.
• Visual Aid Audit - Verify corporate compliance with Visual Aid program through the Visual Aid Audit twice a year.
• Triennial Documentation Review - Assist in the yearly triennial review of documents.
• CoA Issuance - Fulfill CoA requests via Shipping requests and Pharmco CoA Email Inbox to ensure CoA’s are provided for external warehouse shipments and other customer inquiries in a timely fashion.

Additional Skills & Qualifications:

• Bachelor of Science degree preferred
• Strong communication and interpersonal skills
• Proven work experience and qualifications as a collaborative and agile team member
• Strong organization and time-management skills
• Attention to detail is a must

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.