Quality Specialist II – Audit Team

About the Role

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 a proven regulatory track record. The Quality Specialist II - Audit Team drives results in a fast-paced environment by ensuring quality and compliance with applicable regulatory requirements. This role involves reviewing documents and data, supporting audits and inspections, consulting on quality and compliance issues, maintaining quality databases, performing trend analysis, and delivering quality and compliance training. The position also develops SOPs or other quality documents and plays a key role in client audits, including serving as a subject matter expert, supporting audit tours, responding to real-time Q&A, and drafting responses to observations. Additionally, this role creates processes for routine management review of client audit trends, recurring observations, response cycle time, and CAPA effectiveness to drive continuous improvement. The Quality Specialist II - Audit Team may also support internal audits, regulatory inspections, and provide guidance and mentoring to other compliance employees.

Responsibilities

• Performs quality review of complex documents, 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 and advocates for the client within the business unit.
• Identifies deficiencies that require action and supports customer decision-making.
• Serves as a subject matter expert (SME) in client audits, audit tours, and audit response.
• Maintains quality databases and performs analysis and trending.
• Assists with quality improvement initiatives as needed.
• Consults with clients on regulatory issues at all levels.
• Provides consultation on complex quality and compliance topics in areas of expertise.
• Develops and provides training in quality and compliance topics.
• Understands Quality Management Systems, including Investigations, Corrective Actions, and Change Control.
• Serves as an effective member of the Compliance team and mentors others in areas of expertise.
• Complies with company policies and SOPs.
• Ensures timely completion of 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 of relevant experience or equivalent.
• A.A.S. in a related field with 10+ years of relevant experience or equivalent.
• Relevant GMP experience preferred.

Skills

• Strong knowledge of regulations and SOPs applicable to the area of responsibility; stays updated on new regulations and guidance.
• Good written and oral communication skills.
• Proficiency in Microsoft Office products.
• Ability to be trained and to mentor others.
• Strong interpersonal skills to interact well with employees at all levels.
• Good problem-solving skills and attention to detail.
• Ability to negotiate and lead audits.
• Ability to act as a consultant.
• Strong knowledge in one or more of the following areas to support audits: Sterile Manufacturing, Oral Solid Dose Manufacturing, Packaging, Warehouse and Supply Chain, Chemistry Laboratory (large and small molecule), or Microbiology.

Schedule

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00 AM - 5:00 PM.
• Occasional travel to other sites to support audits (up to 10%).

Physical Demands and Work Environment

The physical demands described are representative of those required to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform these 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 frequently required to stand, walk, and sit, and may occasionally be 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 include close vision, distance vision, and peripheral vision.
• The employee may occasionally be exposed to moving mechanical parts, high or precarious places, and vibration. The noise level in the work environment is usually quiet.
• The employee may need to access lab, manufacturing, or clinical areas for inspections or work discussions and is required to wear appropriate personal protective equipment (e.g., safety eyewear, respirators, lab coats, gloves).