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.

About the role

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 required.

This role is heavily involved in client audits, partnering with audit hosts as a subject matter expert, supporting tours, 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. The role also creates processes for routine management review of client audit trends, recurring observations, response cycle time, and CAPA effectiveness to drive continuous improvement.

Additionally, this position may support client audit hosting activities, internal audits, regulatory inspections, and provide guidance and mentoring for 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 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 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.
• Serves as an effective member of the Compliance team and mentors others in area of expertise.
• Complies with company policies and SOPs.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

Requirements

• 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.

Skills

• Strong knowledge of regulations and SOPs applicable to area of responsibility; keeps abreast of new regulations and regulatory guidance.
• Good written and oral communication skills.
• Good computer skills and knowledge of Microsoft Office products.
• Ability to be trained and to mentor others.
• Ability 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 any 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, 8:00am - 5:00pm.
• Occasional travel to other sites to support audits (up to 10%).

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 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 include close vision, distance vision, and peripheral vision.
• 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 and must wear appropriate personal protective equipment (e.g., safety eyewear, respirators, lab coats, gloves).