Quality Specialist II – Audit Team

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

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Job Summary

The Quality Specialist II - Audit Team is accountable for driving results in a fast-paced environment by effectively performing activities directed to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases, performing trend analysis where needed, and performing quality and compliance training as needed. The position develops SOPs or other quality documents as needed.

The Quality Specialist II - Audit Team is heavily involved in client audits. During audits, this position will partner with audit hosts and serve as subject matter experts, supporting tours when appropriate, responding to real-time Q&A, and providing documentation for audit requests. Following receipt of any observations, this position will draft responses, align across sites, ensure appropriate CAPAs are in place, and submit responses in EDMS. This position will create a process for routine management review of client audit trends, recurring observations, response cycle time, and CAPA effectiveness to drive continuous improvement. This position may also support client audit hosting activities, internal audits, and regulatory inspections. The Quality Specialist II - Audit TeamI will provide guidance and mentoring for other compliance employees.

On-Site Expectations

• 100% on-site position.
• Occasional travel to other sites to support Audits.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Performs quality review of complex documents, all types of data, protocols, and/or reports.
• Supports quality floor audits and/or floor inspections.
• Supports client and regulatory agency audits and inspections, as needed.
• Seeks to understand customer needs. Advocates for the client within the business unit.
• Identifies deficiencies that require action and supports customer decision making.
• Serves as SME in client audits, audit tours, and audit response.
• Maintains quality databases and may perform analysis and trending.
• Assists with quality improvement initiatives as needed.
• Consult with clients on all levels of regulatory issues.
• Provides consultation on complex quality and compliance topics in areas of expertise.
• Develops and provides training in quality and compliance topics in areas of expertise.
• Understands Quality Management Systems including Investigations, Corrective Actions, Change Control, etc.
• Serve as an effective member of the Compliance team and serve as a mentor in area of expertise.
• Comply with company policies and SOPs.
• Assist with quality improvement initiatives as needed.
• Ensure timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Qualifications

• B.S./B.A./M.S. in a related field with 2–7 years relevant experience or equivalent.
• A.A.S. in a related field with 10 years relevant experience or equivalent.
• Relevant GMP experience preferred.

Knowledge, Skills, and Abilities

• Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
• Good written and oral communication skills.
• Good computer skills and knowledge of Microsoft Office products.
• Ability to be trained and to mentor.
• Ability to interact well with employees at all levels.
• Good problem-solving skills.
• Good attention to detail.
• Ability to negotiate.
• Ability to lead audits.
• Ability to act as a consultant.
• Strong knowledge in any of the following areas needed to support audits: Sterile Manufacturing, Oral Solid Dose Manufacturing, Packaging, Warehouse and supply chain, Chemistry Laboratory (large and small molecule), or Microbiology.

Travel Expectations

• Up to 10% travel is required to sites for audits.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.