Data Quality Review Supervisor - QC Data Review

 

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.

Are you interested in joining our team?

Job Summary

The Supervisor, Data Quality Review is accountable for driving results in a fast-paced environment, continuously challenging performance in regards to quality standards, systems and operating procedures. The Supervisor, Data Quality Review is responsible for scheduling work for the team, developing SOPs or other quality documents as needed, and providing consultation on quality and compliance topics in areas of expertise.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:30am - 5:30pm.

Responsibilities

• Interacts with clients and regulatory agencies as needed regarding quality issues, audits, and inspections, and hosts client audits.
• Collaborates with other supervisors in quality, labs, and manufacturing.
• Oversees the distribution of work to ensure efficiency and achievement of department goals. 
• Performs data review of lab documentation, protocols, reports, investigations, test procedures, and other documentation on schedule, with accuracy and competency.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching, and mentoring and performance management.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Microbiology or equivalent required. 
• Minimum 6 years of related pharmaceutical laboratory experience in a cGMP environment required.
• 1-2 years of leadership experience preferred. 
• Prior CMO or CDMO experience strongly preferred. 
• Prior experience in method development/validation and/or transfer/verification, protocols, and troubleshooting required.

Knowledge, Skills, and Abilities

• Excellent knowledge of cGMP in a pharmaceutical or regulated environment required.
• Working knowledge of method development/validation and/or transfer/verification and protocols.
• Working knowledge of pharmaceutical microbiology testing, analytical testing, and quality principles in a cGMP environment. 
• Working knowledge of raw material, in-process and finished product testing, e.g. Microbial Limit Tests, Endotoxin, Sterility, utility testing, ID, appearance, cleaning methods, HPLC, TOC, conductivity and osmolality (or some combination).  
• Superior documentation skills and thorough understanding of client management.
• Excellent leadership, communication and presentation skills.
• Excellent skills in strategic planning, problem solving, root-cause analysis and critical thinking required.
• Excellent verbal communications and presentation skills required.
• Proficiency with Microsoft Office (Word, Excel, PowerPoint) required.
• Proficiency with electronic systems (Empower, MODA, NuGenesis, etc.)

Travel Expectations

• Up to 5% travel required.

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 is required to frequently talk or hear. The employee is required some of the time to stand, walk, and sit. The employee is required to occasionally use hands to finger, handle, or feel; climb or balance; stoop, kneel, crouch or crawl; reach with hands and arms; taste or smell. The employee must regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 50 pounds. There is no special vision requirement for this job. The employee may occasionally work in wet or humid conditions, near moving mechanical parts, in high precarious places, near fumes, airborne particles or toxic chemicals.