GMP Document Control Specialist — Quality & Compliance

Talentify; Oak Hill (WV); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

401(k) plan

Tuition reimbursement

Parental leave

Healthcare coverage for employee and a

Job summary

Haleon in the United States seeks a Document Control Specialist to support regulatory compliance and quality system activities. Manage the Document Control Application as Local Business Administrator and serve as site point of contact to deploy and enhance the network tool, ensuring timely GMP document approvals.

In this role you will participate in network meetings, support document authors and reviewers, maintain lifecycle workflows, and contribute to continuous improvement while upholding

Qualifications

• Bachelor's degree in the listed fields.
• 2+ years in a regulated GMP environment.

Responsibilities

• Responsible for the Document Control Application as Local Business Administrator.
• Acts as Site Point of Contact to deploy or enhance the network Document Control Application.
• Participates in DCA network meetings to identify improvements and solve technical issues.
• Quality review & approval of GMP documents to ensure requirements are met.
• Provides support to document authors, reviewers, and approvers to maintain the documents process flow and lifecycle.
• Keeps and manages the Contingency plan to provide documentation such as Standard Operating procedures, forms, training assessment, etc.
• Supports implementation and sustainment of quality systems that may include quality standards and electronic tracking systems.
• Supports the audit and inspection processes
• Maintains knowledge and understanding of cGMPs, product types, and any additional training requirements for assigned tasks
• Identifies and lead implementation of continuous improvement opportunities
• Participates in projects or assigned tasks related to identify impact in the GMP documentation
• Adheres to all safety guidelines and procedures
• Provides support, as required, to Quality System functions
• Performs tasks assigned by the Manager

Skills

GMP experience

Regulatory compliance knowledge

Education

Bachelor's degree in Business Administration, Biology, Microbiology, Chemistry, Biochemistry, Pharmacy or Management

Job description

Haleon in the United States seeks a Document Control Specialist to support regulatory compliance and quality system activities. Manage the Document Control Application as Local Business Administrator and serve as site point of contact to deploy and enhance the network tool, ensuring timely GMP document approvals.

In this role you will participate in network meetings, support document authors and reviewers, maintain lifecycle workflows, and contribute to continuous improvement while upholding