Job Summary

The Specialist I, QA Compliance is responsible for independent QA oversight of each Quality System in support of commercial product manufacturing at the site and manages activities for one or more Quality System or cross-functional project.
The Specialist I, QA Complance will provide a broad scope of technical knowledge to analyze risk, troubleshoot highly complex issues, support quality systems and plant compliance. They apply expertise and regulatory knowledge to support change and risk management.

Essential Functions

Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.
• Represent the department in interactions with internal functional units and external contract partners or regulatory officials
• Critically review various types of documentation to ensure completeness, accuracy, and compliance including but not limited to regulatory submissions, product complaints, annual product reviews, Quality Agreements, Supplier Notifications, Request for Proposals, SOPs, master plans, deviation investigations, CAPAs and change controls
• Support Supplier Quality Program including conducting Supplier Audits, as assigned
• Develop and revise Quality Technical Agreements and supplier notification of changes to ensure impact is thoroughly assessed prior to implementation and liaise on investigations of nonconformities for suppliers providing products or services in support of GMP operations
• Lead or participate in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product
• Plan, schedule and conduct internal and external (supplier) quality system audits per audit schedule. This includes a review of prior internal audits and regulatory inspections, reviewing procedures, processes and activities in creating the audit plan
• Drive inspection readiness strategy and activities and serve as a subject matter expert in quality systems
• Prepare functional and Management Review metrics for identification of negative trends. Conduct analysis of identified negative trends and propose/implement necessary corrections to address and present to Management team
• Frequently interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decisions.

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

Education, Experience & Skills
• Bachelor's Degree in Scientific or related fields
• A minimum of six (6) years of cGMP Quality experience
• Strong Commercial manufacturing experience (Large Molecules) required
• Quality Auditor, Six Sigma, or equivalent certification/education preferred
• Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards
• Expert Knowledge and application of GMP principles
• Excellent communication skills: oral/written and listening
• Excellent facilitation and presentation skills
• Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability, decision making, coaching,
• Interpersonal skills: team building, consensus building, conflict resolution
• Critical analytical skills, strong verbal and communication skills
• Must be able to critically evaluate data summaries and conclusions
• Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.
• Ability to influence without authority across cross-functional organization

Physical/Mental Requirements

Type/keyboard, visual acuity, stand, walk, sit, squat/kneel, sense of hearing, and lift/carry 15 lbs. Use phone, fax, copier and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, plan, communicate and prepare written communications.

U.S. Base Pay Ranges and Benefits Information

The estimated annual base salary as a new hire for this position ranges from $129,000 to $156,000. Individual base pay depends on various factors such as applicant's education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant's geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, [and/or long-term incentives in the form of stock options.]

Additionally, Emergent offers a comprehensive benefits package*. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent

(*Eligibility for benefits is governed by the applicable plan documents and policies).

If you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.