Quality Assurance Manager at GRANULES CONSUMER HEALTH LLC

Manassas, Virginia, United States -

Full Time

Start Date

Immediate

Expiry Date

22 Dec, 25

Salary

0.0

Posted On

23 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CgmP Compliance, FDA Regulations, ICH Guidelines, Quality Operations Management, Training Requirements, Quality Document Management, Audit Inspections, Validation Documents, Quality Assurance Support, Staff Development, Succession Planning, Continuous Improvement, Quality Management Systems, Regulatory Affairs, Problem Solving, Communication

Industry

Description

Description *This is an Onsite Role** The QA Manager ensures compliance with cGMP and internal policies, procedures and specifications. This position is responsible for performing documentation for all quality system functions in accordance with cGMP and related company SOP’s, state, federal and local laws as applicable. This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines. The person will be responsible for managing and ensuring that facility meets all GMP, FDA and SOP requirements. Managing all quality operations to include inspection of components, bulk, and final products for the Manassas, VA, ensuring release lead times are met with timely product disposition. Ensure that the facility is meeting all training requirements. Lead the communication of open quality document notification and resolution between all departments regarding Complaints, Investigations, Change Control, CAPA’s (including verification of CAPA’s) and other quality documents as needed. Manage and maintain audit inspections (Internal and External) for the site. Responsible for supporting the preparation, review, processing, and approval of various validation documents as application for the Granules, Manassas, facility. Provide QA support, review and approval for relevant documents including relevant procedures, batch records, specifications, stability reports, technical reports (i.e., Qualification, Validation, Transportation.), trend reports, Annual Product Quality Reviews and other documents as needed. Responsible for performance and development of all Quality Assurance staff through mentoring and focusing on personal and professional growth. Work with Quality leadership team for proactive succession planning and a high-performance culture through people. Guide and lead by setting realistic personal goals for staff and provide regularly scheduled feedback throughout the year. Provide the means for incorporating the necessary tools, equipment, and methods into the new and existing processes aimed at continuous improvement. Implementation Quality management system tools and their compliance. Development and execution of quality training modules for the organization. Ensure staff receives appropriate knowledge and skill development and growth opportunities Work with Regulatory Affairs to supply information needed for FDA filings. Other duties as assigned by management

Responsibilities

The QA Manager ensures compliance with cGMP and internal policies, managing all quality operations including inspections and documentation. They lead communication regarding quality documents and manage audit inspections for the facility.