Quality Specialist 1

 

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 I provides site quality support in a fast-paced environment by effectively performing activities of substantial variety to ensure quality and compliance with applicable regulatory requirements and is proficient in document reviews applicable to the respective processes executed at the respective lab, manufacturing facility, compliance, or regulatory team. Activities include reviewing documents and data, supporting audits and inspections, consulting with support or guidance from Quality team/management on quality and compliance issues, maintaining quality databases, and performing quality and compliance training as needed. The position assists in developing or revising SOPs or other quality documents as needed. The QA Specialist I is a model to all other departments for adherence to GMP and regulations. The role works on problems of basic scope in which analysis of situations or data requires a review of identifiable factors, exercises judgment within defined procedures and practices to determine appropriate action and escalates when needed.

On-Site Expectations

• 100% on-site position.
• 2nd Shift: Monday - Friday, 2:30pm - 11:30pm.

Responsibilities

• Performs quality review of moderately complex documents, various types of data, protocols, and/or reports.
• Supports quality floor audits and/or floor inspections.
• Provides real-time, on-the-floor review of documentation.
• Supports client and regulatory agency audits and inspections, as needed.
• Maintains quality databases and may perform analysis and trending.
• Assists with quality improvement initiatives as needed.
• Assists with the development or revisions to quality SOPs or other quality documents and/or reports as needed.
• Provides consultation on quality and compliance topics in areas of expertise.
• Provides training in quality and compliance topics in areas of expertise.
• Understands Quality Management Systems including Investigations, Corrective Actions, Change Control, etc.
• Effectively performs a variety of moderately complex duties, on schedule, with accuracy.
• Maintains accurate files and records.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Acts with support to conduct routine assignments.
• Works to master basic Quality business unit tasks applicable to the role.
• Other duties as assigned.

Qualifications

• B.S./B.A./M.S. in a related field with 0–2+ years relevant experience or equivalent.
• A.A.S. in a related field with 5+ years relevant experience or equivalent.
• Relevant GMP experience preferred.

Knowledge, Skills, and Abilities

• Academic exposure to skills in applicable functional area with potential for technical proficiency when possible.
• Able to comply with SOPs and regulatory compliance.
• Basic knowledge of quality and regulatory concepts, principles, and procedures.
• Excels in Right First Time.
• Actively and positively engages with team and supports process improvements.
• Works on basic problems and applies practical problem-solving methods with supervision.
• Requires detailed and specific instructions to complete assignments.
• Works to master basic Quality business unit tasks applicable to the role.
• Basic computer skills including familiarity with computer software such as ERP, EDMS, Microsoft Word, PowerPoint, and Excel.
• Ability to take directions from experienced team members and contributes in a team environment.
• Effective team member.
• Good problem-solving skills.
• Good attention to detail.
• Can repeat and follow detailed scientific procedures with supervision.
• Able to clearly present results verbally in group meetings and in written progress reports.
• Good interpersonal skills and is willing to ask questions about procedures and concepts.
• Aptitude and willingness to gain more skills and knowledge in support of GMP regulations.
• Good written and verbal communication skills.

Travel Expectations

• Up to 5% travel required.

Physical Demands and Work Environment

The physical demands and work environment characteristics 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, or manufacturing areas for inspections or work discussions. The noise level in these additional work areas may be louder. 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.