Specialist I, QA Compliance

About the role

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. This role provides a broad scope of technical knowledge to analyze risk, troubleshoot highly complex issues, support quality systems, and ensure plant compliance. The Specialist applies expertise and regulatory knowledge to support change and risk management.

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.

Responsibilities

• 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 the 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; 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 to analyze issues, determine root cause, identify corrective and preventive actions, and assess impact to product.
• Plan, schedule, and conduct internal and external (supplier) quality system audits per audit schedule, including reviewing prior internal audits and regulatory inspections, procedures, processes, and activities to create 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 to identify negative trends; conduct analysis of identified trends and propose/implement necessary corrections, presenting findings to the Management team.
• Frequently interact with senior leadership, direct manager, peers, internal customers, external clients, and other cross-functional peers across Emergent to gain alignment on sound quality decisions.

Requirements

• Bachelor’s Degree in Scientific or related field.
• 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.
• Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.

Skills

• Excellent communication skills: oral, written, and listening.
• Excellent facilitation and presentation skills.
• Strong interpersonal skills: team building, consensus building, conflict resolution.
• Critical analytical skills; ability to evaluate data summaries and conclusions.
• Ability to influence without authority across a cross-functional organization.
• Personal competencies: self-awareness, integrity, judgment, vision, adaptability, decision-making, and coaching.

Physical/Mental Requirements

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

Pay

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, abilities, internal equity, and alignment with market data. The salary may also be adjusted based on the 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.

Benefits

Emergent offers a comprehensive benefits package. Eligibility for benefits is governed by the applicable plan documents and policies. More information can be found here.