Quality Specialist

Position Summary

The Quality Specialist is accountable for driving results in a fast-paced environment by effectively performing activities of some variety and complexity to ensure quality and compliance with applicable regulatory requirements. These activities may include reviewing documents and data, conducting basic floor audits and processes inspections, consulting on quality and compliance issues, maintaining quality databases and performing trend analysis where needed, and performing quality and compliance training as needed. The Quality Specialist assists with the development of SOPs or other quality documents as needed. The position requires superior leadership behaviors of the Alcami core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

Essential Functions

• Performs quality review and approval of documents, all types of data, protocols, and/or reports.
• Performs complex quality floor audits and/or floor inspections.
• Provides quality evaluation and release of support materials, products, equipment and facilities as required.
• Maintains quality databases and may perform analysis and trending.
• Assists with quality improvement initiatives as needed.
• Perform visual inspection on finished product for AQL Testing.
• Assists with development/writing of SOPs or other quality documents and/or reports as needed.
• Provides consultation on quality and compliance topics in areas of expertise.
• Provide training in quality and compliance topics in areas of expertise.
• Serves as client quality liaison and/or quality host of client audits; coordinates responses to client audits.
• Maintains accurate files and records.
• Serves as an effective member of the Quality team and may serve as a mentor to other Quality employees in the area of expertise.
• Complies with company polices and SOPs.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Education and Experience

• Bachelors degree in Chemistry, Biology, or related field with 3 years GMP related experience, or Masters degree in related field with 1 years related experience, or equivalent educational and work experience.

Alcami Non-Negotiables

• Consistently demonstrates honesty and integrity through personal example.
• Follows all safety policies and leads by example a safety first culture.
• Produces high quality work product with a focus on first time right.
• Complies with the company code of conduct and policies and regulatory standards.

Alcami Core Leadership Competencies

• Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
• Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
• Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
• Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
• Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
• Works collaboratively. Seeks out the experience of others with the aim for better results. Open minded regardless where ideas originate. Flexible and easy to work with.

Functional Competencies

• Strong knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
• Excellent written and oral communication skills.
• Good math skills.
• Ability to be trained and to mentor.
• Ability to act independently.
• Ability to interact well with employees at all levels.
• Ability to host audits.
• Proficiency with Microsoft Office products.

Travel Requirements

• Up to 5% travel required.