Quality Assurance Manager

Description

Brief Job Overview

This is a hands-on, individual contributor position that supports the important work of USP’s 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 USP's public health mission of increasing equitable access to high-quality, 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).DEPTFORM-00250-04– Effective 01-October-2024
• Lead investigations resulting from the ARM/RS lifecycle, publications and information technology activities by conducting root cause analysis, risk assessment, corrective actions, follow-up to closure and effectiveness checks.
• Establish and maintain databases for tracking quality metrics. Analyze databases information for trending and reporting purposes on pre-established frequency.
• Execute the audit plan and provide robust audit reports within pre-established 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 multi-functional 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:

• Bachelor’s degree in a science field and a minimum of 5-7 years of relevant quality assurance and/or quality control experience in a pharmaceutical or other regulated industry.
• Minimum of 2 years of cross-functional team experience.
• Proficient in excel, word, access, power point software applications.

Additional Desired Preferences

• Master’s 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 well-developed 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 fast-paced environment.
• Excellent written and verbal communications skills.
• Well-developed 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 company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected.

Compensation

Base Salary Range: USD $97,000.00 - $124,750.00 annually.

Target Annual Bonus: 13% Varies based on level of role.

Individual compensation packages are based on various factors unique to each candidate’s skill set, experience, qualifications, equity, and other job-related 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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)