STAQ Pharma is currently hiring for a Quality Assurance Manager in our Denver Facility
Ready to make your application Please do read through the description at least once before clicking on Apply.
Salary : $100K-$110K / year
The Quality Assurance Manager provides leadership in the implementation and oversight of the Quality Management System (QMS) at STAQ Pharma, Inc.
This role gives guidance for resolution of daily quality issues and opportunities for improvement to ensure Current Good Manufacturing Practices (CGMP) compliance.
Large scale enhancement projects to improve process inefficiencies, eliminate risk, and drive towards may be led by the Quality Assurance Manager.
The position leads regulatory inspections and customer audits, and facilitates the supplier management program to ensure the quality of services and incoming goods.
Roles and Responsibilities
- Author, review and / or approve Standard Operating Procedures (SOPs) and Work Instructions to maintain compliance with CGMP requirements and product quality standards.
- Oversee the batch review and disposition process to ensure products meet CMGP requirements and all unexplained discrepancies are investigated.
- Manage Quality department metrics for Management Review and routine Key Performance Indicators (KPIs).
- Serve as QA subject matter expert during regulatory inspections and customer audits. Maintain company audit readiness and support document requests made during inspections and audits.
- Perform and / or review deviation and CAPA investigations for root cause analysis, corrective actions, and effectiveness checks.
Drive CAPA plans to completion in a timely manner.
- Plan, maintain, and implement the internal audit schedule and ensure audits, responses, and corrective action is taken in a timely manner.
- Lead the supplier management program to evaluate new suppliers, perform ongoing oversight of suppliers including audits, communicate complaints, and manage supplier corrective action requests.
- Review change controls to manage the risk and impact to validated CGMP systems, processes, and equipment.
- Support Quality and company goals related to the QMS.
- Coach and mentor Quality Assurance department staff to support and execute CGMP processes.
- Other duties as assigned.
Qualifications and Education Requirements
- 5 to 7 years experience in a CGMP environment, preferrably in a decision making or leadership role.
- B.S. or B.A., at a minimum.
- Comprehensive knowledge of applicable FDA regulations and guidance documents.
- Previous experience as a key member of regulatory inspections and customer audits.
- Strong analytical knowledge of data and associated statistical tools.
- Technical writing skills to accurately convey information to the intended audience.
- Excellent verbal communication skills.
Preferred Skills
- Experience implementing lean manufacturing and 5S methodologies.
- Advanced Microsoft Office product skills (e.g., Word, Excel).
Quality Assurance Manager
The Quality Assurance Manager is responsible for providing leadership, direction, and resource stewardship for Quality in our Denver, CO Stoneworks manufacturing facility. The role reports to Corporate Quality Regional Leadership with a dotted line reporting to the Plant Manager they support. T...
Quality Assurance Manager
The Quality Assurance Manager ensures compliance to FDA Quality System Regulations and ISO13485 standards for all quality system processes and procedures. They direct Quality Assurance and Quality Engineering activities to foster a culture of continuous improvement. They direct the Quality Assurance...
Quality Assurance Manager - Unarmed - Denver
Quality Assurance Manager - Unarmed - Denver. The QA Manager will perform after-hour inspections at various facilities throughout the Denver metro area to ensure employees are representative of ASI and customers’ expectations. The QA Manager will also serve as a liaison between company management, c...
Quality Assurance Manager
The Quality Assurance Manager provides leadership in the implementation and oversight of the Quality Management System (QMS) at STAQ Pharma, Inc. STAQ Pharma is currently hiring for a Quality Assurance Manager in our Denver Facility. Large scale enhancement projects to improve process inefficiencies...
Environmental Quality Assurance Manager/Sr. Chemist (Hybrid/Remote Work)
Conduct technical reviews and prepare technical reports and other documents on topics associated with data quality/quality assurance. Prepare and review Uniform Federal Policy Quality Assurance Project Plans (UFP-QAPPs). Serve as project manager acting as client liaison on technical and project stat...
Quality Assurance Manager
The Quality Assurance Manager is responsible for providing leadership, direction, and resource stewardship for Quality in our Denver, CO Stoneworks manufacturing facility. The role reports to Corporate Quality Regional Leadership with a dotted line reporting to the Plant Manager they support. At lea...
Program Manager - Clinical Quality Assurance (Remote)
Manage all Quality Control and Quality Assurance staff including Manager(s), Supervisor(s), and Analyst(s) - Direct all quality monitoring activities including planning, implementation, monitoring and reporting functions - Collaborate with technical staff to design and develop reports ...
Quality Assurance Manager
The successful candidate will have at least 3+ years of manufacturing experience and at least 1 years of quality experience/process or production engineering experience and at least some exposure to quality management / experience. Enthusiastic about the value/yield quality brings to the manufacturi...
Environmental Quality Assurance Manager/Sr. Chemist (Hybrid/Remote Work)
Conduct technical reviews and preparing technical reports and other documents on topics associated with data quality/quality assurance. Prepare and review Uniform Federal Policy Quality Assurance Project Plans (UFP-QAPPs). Serve as project manager acting as client liaison on technical and project st...
Quality Assurance Manager
The Quality Assurance Manager provides leadership in the implementation and oversight of the Quality Management System (QMS) at STAQ Pharma, Inc. STAQ Pharma is currently hiring for a Quality Assurance Manager in our Denver Facility. Large scale enhancement projects to improve process inefficiencies...