Quality Assurance Manager
Quality Assurance Manager
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Job Description
Who is USP
The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the worlds top authorities in health and science to develop quality standards for medicines dietary supplements and food ingredients. USPs fundamental belief that Equity Excellence manifests in our core value of Passion for Quality through our more than 1300 hardworking professionals across twenty global locations to deliver the mission to strengthen the supply of safe quality medicines and supplements worldwide.
At USP we value inclusivity for all. We recognize the importance of building an organizational culture with meaningful opportunities for mentorship and professional growth. From the standards we create the partnerships we build and the conversations we foster we affirm the value of Diversity Equity Inclusion and Belonging in building a world where everyone can be confident of quality in health and healthcare.
USP is proud to be an equal employment opportunity employer (EEOE) and affirmative action employer. We are committed to creating an inclusive environment in all aspects of our workan environment where every employee feels fully empowered and valued irrespective of but not limited to race ethnicity physical and mental abilities education religion gender identity and expression life experience sexual orientation country of origin regional differences work experience and family status. We are committed to working with and providing reasonable accommodation to individuals with disabilities.
Brief Job Overview
This is a handson individual contributor position that supports the important work of USPs Quality Assurance (QA) team in support of the Microbiology business unit. The incumbent will work independently with some oversight and will be primarily responsible for QA tasks related to the microbiology pipeline including microbial Analytical Reference Materials (ARMs) and reference standards. The incumbent anticipates and solves problems and issues within his/her area of responsibility. In addition the incumbent designs develops and implements new tools and techniques used in the overall Quality Systems.
How will YOU create impact here at USP
In this role at USP you contribute to USPs public health mission of increasing equitable access to highquality safe medicine and improving global health through public standards and related programs. In addition as part of our commitment to our employees Global People and Culture in partnership with the Equity Office regularly invests in the professional development of all people managers. This includes training in inclusive management styles and other competencies necessary to ensure engaged and productive work environments.
The Quality Assurance Manager has the following responsibilities:
- Ensures understanding usage implementation and maintenance of the Quality Management System (QMS).
- Lead investigations resulting from the ARM/RS lifecycle publications and information technology activities by conducting root cause analysis risk assessment corrective actions followup to closure and effectiveness checks.
- Establish and maintain databases for tracking quality metrics. Analyze databases information for trending and reporting purposes on preestablished frequency.
- Execute the audit plan and provide robust audit reports within preestablished timeframes.
- Leads the annual management review meeting including scheduling preparing the meeting agenda gathering pertinent information from department heads and compiling and distributing the meeting record.
- Attend and participate on key multifunctional team meetings that are part of the development lifecycle providing QA input as required.
- Be an effective participant of internal and external departmental process improvement teams and long term projects effectively to achieve a common resolution.
- Prepare and support as required for ISO 9001 certification and/or ISO 17034 certification.
- Provides support to management and be a resource to staff to achieve goals.
- Provide internal and external department training as required.
- Demonstrates use of quality improvement in daily work and operations and advocate for quality initiative to other departments.
- Tracks project status for department. Creates and distributes detailed project status reports to all staff in department to facilitate decision making about new project assignments
Who is USP Looking For
The successful candidate will have a demonstrated understanding of our mission commitment to excellence through inclusive and equitable behaviors and practices ability to quickly build credibility with stakeholders along with the following competencies and experience:
- Bachelors degree in a science field and a minimum of 57 years of relevant quality assurance and/or quality control experience in a pharmaceutical or other regulated industry.
- Minimum of 2 years of crossfunctional team experience.
- Proficient in excel word access power point software applications.
Additional Desired Preferences
- Masters Degree in science or Engineering.
- Experience creating and maintaining quality systems for a pharmaceutical or medical device product.
- Experience related to microbiology or biological science.
- Quality control testing experience.
- Advanced understanding of ISO 9001/ ISO 17034 and ISO 17025.
- Knowledge of use of USP Compendia (Monographs General Chapters).
- Knowledge of FDA regulations other Compendia and ICH guidelines.
- Demonstrated skills in audit planning reporting and lead auditing techniques with previous CQA or lead auditor training experience.
- Ability to listen interpret and influence without direct authority in a cooperative and friendly manner.
- Detail oriented with welldeveloped organizational and prioritization skills.
- Results and timeline driven with demonstrated successful outcomes.
- Ability to handle multiple priorities and shift priorities as a result of a fastpaced environment.
- Excellent written and verbal communications skills.
- Welldeveloped presentation and meeting facilitation skills.
- Demonstrated excellent verbal and written communication skills.
- Ability to explain complex information simply to a diverse audience.
- Experience on research and development instrumentation techniques and analytical skills.
- Proficient on word excel power point access software applications as a minimum.
Supervisory Responsibilities
None this is an individual contributor role.
Benefits
USP provides the benefits to protect yourself and your family today and tomorrow. From companypaid time off and comprehensive healthcare options to retirement savings you can have peace of mind that your personal and financial wellbeing is protected.
Compensation
Base Salary Range: USD $97000.00 $124750.00 annually.
Target Annual Bonus: 13 Varies based on level of role.
Individual compensation packages are based on various factors unique to each candidates skill set experience qualifications equity and other jobrelated reasons.
Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP.
Required Experience:
Manager
Employment Type
Full-Time
