Granules Pharmaceuticals, Inc.
Quality Assurance Manager
Granules Pharmaceuticals, Inc., Manassas, Virginia, United States, 22110
Quality Assurance Manager – Focused Service
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. The QA Manager should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines.
Responsibilities
Manage and ensure the facility meets all GMP, FDA and SOP requirements.
Manage all quality operations including inspection of components, bulk, and final products for the Manassas, VA facility, ensuring release lead times are met with timely product disposition.
Ensure compliance with training requirements.
Communicate open quality document notifications and resolution between departments regarding Complaints, Investigations, Change Control, CAPA’s and other quality documents as needed.
Manage and maintain audit inspections (internal and external) for the site.
Support the preparation, review, processing and approval of various validation documents for the Granules, Manassas facility.
Provide QA support, review and approval for relevant documents including procedures, batch records, specifications, stability reports, technical reports, trend reports, Annual Product Quality Reviews and other documents as needed.
Perform performance and development of all QA staff through mentoring and focusing on personal and professional growth.
Work with the 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.
Incorporate necessary tools, equipment and methods into new and existing processes aimed at continuous improvement.
Implement quality management system tools and maintain compliance.
Develop and execute 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.
Qualifications
Expert-level knowledge of the FDA guidance for industry, Title 21 of the Code of Federal Regulations and Compendia (USP/EP/BP/etc.)
cGMP compliance within the pharmaceutical manufacturing industry.
Writing and maintaining cGMP documentation.
Analyze data/information and resolve complex issues.
Verbal and written communication skills.
Work and communicate with cross-functional teams.
Multiple priorities and re-prioritize tasks.
Strong computer skills and working knowledge of Microsoft Office Suite and Adobe.
Demonstrated ability to work on complex assignments in collaboration with various departments.
Bachelor's degree in the life sciences (or equivalent work experience) with a minimum of 6+ years in a QA role within the pharmaceutical industry.
Master’s degree with 4+ years of pharmaceutical manufacturing experience and at least 3 years progressive challenging QA experience in the pharmaceutical industry.
Physical Requirements / Working Environment
Regularly required to stand, sit, talk, hear and use hands and fingers to operate a computer and telephone keyboard.
Close vision required due to computer work.
Ability to sit at a computer terminal for an extended period of time.
Light to moderate lifting up to 10-15 lbs is required.
Ability to work in a confined area.
#J-18808-Ljbffr
Responsibilities
Manage and ensure the facility meets all GMP, FDA and SOP requirements.
Manage all quality operations including inspection of components, bulk, and final products for the Manassas, VA facility, ensuring release lead times are met with timely product disposition.
Ensure compliance with training requirements.
Communicate open quality document notifications and resolution between departments regarding Complaints, Investigations, Change Control, CAPA’s and other quality documents as needed.
Manage and maintain audit inspections (internal and external) for the site.
Support the preparation, review, processing and approval of various validation documents for the Granules, Manassas facility.
Provide QA support, review and approval for relevant documents including procedures, batch records, specifications, stability reports, technical reports, trend reports, Annual Product Quality Reviews and other documents as needed.
Perform performance and development of all QA staff through mentoring and focusing on personal and professional growth.
Work with the 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.
Incorporate necessary tools, equipment and methods into new and existing processes aimed at continuous improvement.
Implement quality management system tools and maintain compliance.
Develop and execute 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.
Qualifications
Expert-level knowledge of the FDA guidance for industry, Title 21 of the Code of Federal Regulations and Compendia (USP/EP/BP/etc.)
cGMP compliance within the pharmaceutical manufacturing industry.
Writing and maintaining cGMP documentation.
Analyze data/information and resolve complex issues.
Verbal and written communication skills.
Work and communicate with cross-functional teams.
Multiple priorities and re-prioritize tasks.
Strong computer skills and working knowledge of Microsoft Office Suite and Adobe.
Demonstrated ability to work on complex assignments in collaboration with various departments.
Bachelor's degree in the life sciences (or equivalent work experience) with a minimum of 6+ years in a QA role within the pharmaceutical industry.
Master’s degree with 4+ years of pharmaceutical manufacturing experience and at least 3 years progressive challenging QA experience in the pharmaceutical industry.
Physical Requirements / Working Environment
Regularly required to stand, sit, talk, hear and use hands and fingers to operate a computer and telephone keyboard.
Close vision required due to computer work.
Ability to sit at a computer terminal for an extended period of time.
Light to moderate lifting up to 10-15 lbs is required.
Ability to work in a confined area.
#J-18808-Ljbffr