QC Lab Supervisor

Job purpose

The lab and quality control supervisor directs and upholds the highest standards in production by overseeing sterile compounding processes and quality control procedures, ensuring the delivery of safe and accurate patient prescriptions.

This role oversees commercial compounding activities related to named-patient products (NPP), specifically subcutaneous immunotherapy treatment sets and sublingual immunotherapy treatment sets. Supervising a team of lab technicians and QC final checkers, the lab and quality control supervisor plays a crucial role in ensuring product quality. This pivotal role also keeps a close eye on evolving regulatory requirements and proposes improvements that will help us continue to meet quality standards for NPP products and processes.

Additionally, this role engages with customers as needed to provide insights and answer questions over the phone and email; and may also occasionally represent the company at conferences and events.

General requirements

Employees must fulfill the following general requirements for employment at Stallergenes Greer, including but not limited to:

• Complies with applicable standard operating procedures (SOPs).
• Adheres to policies, standards, and guidelines.
• Fulfills requirements of role training curriculum.
• Updates job knowledge by participating in training and development opportunities.
• Practices good hygiene and personal sanitation practices.
• Protects and preserves Stallergenes Greer physical property and equipment.
• Protects and preserves Stallergenes Greer intellectual property and confidential information.
• Conducts all interactions with stakeholders in a professional and ethical manner.

Education requirements

• University degree or equivalent in a science related to the work being carried out.

Work experience requirements

• Some related and/or transferrable experience; or
• Combination of education and experience.

Job tasks/responsibilities

· Lab processes. Oversees sterile filling processes, lab SOPs and documentation:

• Review daily and monthly logs, ensuring accuracy, completeness, GDP, and that all SOPs are followed (e.g., temperature logs and records, cleaning logs, environmental monitoring, etc.)
• Observe and evaluate lab media fills, lab competencies, etc.
• Supports SOP development and updates as a subject matter expert Completes sterile compounding of named patient products, as needed.
• Lab inventory is managed in Sage, with product entered accurately.
• Quality control for NPP. Ensures NPP product meets all quality standards before it is released.
• Maintains formulation standards and ensures calculations are correct.
• Ensures a complete and consistent final checking process for all NPP products, including thorough reviews of doctor orders and attached paperwork to ensure all patient products are accurate and correct; and visual analysis of vials, labels, packaging and paperwork to ensure quality, consistency and accuracy.

Supervise workflow. Ensures that all named patient products are filled and quality reviewed in a timely manner without unreasonable delay or order backlog that can cause an issue for patients.

• Prioritizes workflow to meet customer commitments whenever possible (without compromising quality standards).
• Communicates when a commitment isn’t possible to be met because of a quality issue.

· NPP quality system. Ensures quality mindset is applied for NPP:

• Chairs monthly NPP Quality review committee (QRC) meetings.
• Completes quality calendar activities as needed.
• Ensures timely completion of intake forms as needed, meeting reporting deadlines.
• Completes local investigations for complaints as needed.
• Initiates deviations and change controls as needed.
• Flags any out of norm situations for immediate investigation.
• Maintains consistent file management and version control following established standards.
• Meets as a team regularly to identify roadblocks, issues or trends for investigation and resolution.
• Shares constructive feedback directly with other team members when there are correction trends.
• Works with site manager to recommend upgrades and/or replacements to equipment and facilities.·
• Technical oversight. Answers technical product questions and escalates to medical for follow-up as needed.

· Lab & QC supply management.

• Oversees lab extract inventory (i.e., entering working stock in Sage, TOS, BOMs, etc.).
• Ensures adequate supply of materials are available and submits purchase requests as needed (e.g., boxes, box inserts, dosage schedules, etc.).

· Team leadership. Provides leadership to lab technicians and QC final checking team:

• Actively participates in employee development, with the aim of helping them reach their potential.
• Provides timely coaching, guidance and feedback for direct report(s).
• Conducts regular 1:1 meetings with direct reports.
• Conducts performance evaluations for direct report(s).
• Recruits, interviews and onboards new team members.
• Completes all documentation according to GDP.
• Comes prepared for weekly 1:1 meetings with supervisor.
• Submits timely and accurate reporting.
• Contributes to team effort by completing other work as needed.

Physical demands

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 sit for extended periods of time, looking at a computer screen. Eye and muscle strain, backaches, headaches, and repetitive motion injuries can be avoided by applying ergonomic principles.

Computer skills

• Proficient in MS Office (Word, Excel, PowerPoint, Outlook, Teams).
• Aptitude and willingness to learn new technologies.

Additional skills

• Leadership and management skills: coaching, delegation, feedback, staffing, performance management.
• Demonstrates basic math skills.
• Pays careful attention to details and is thorough in completing tasks.
• Communicates clearly and effectively.
• Engages with honesty and respect, understanding that healthy conflict can lead to creativity and better solutions.
• Chooses to remain pleasant and helpful, displaying a cooperative attitude.
• Manages time and priorities well.
• Models a continuous improvement mindset and looks for opportunities to improve: both own performance and processes within the team.
• Demonstrates integrity by being transparent, authentic, fair and ethical.

Direct reports

Lab technicians, QC final checking

Job Type: Full-time

Work Location: In person