QC Supervisor – Biochemistry

Overview:

The QC Supervisor supervises and coordinates personnel performing analytical services support required for quality control of processes and products. The individual supervises the performance of daily testing, assuring appropriate resources are scheduled and equipment is fit for purpose. The individual is a primary contact for the Quality Control laboratory, collaborating with staff outside of the department, facilitating timely and right first time data management and reporting, and assuring that manufacturing schedules are met. The supervisor has direct impact on department/group performance through resource management and task scheduling.

Responsibilities:

The QC Supervisor supervises and coordinates personnel performing analytical services support required for quality control of processes and products. The individual supervises the performance of daily testing, assuring appropriate resources are scheduled and equipment is fit for purpose. The individual is a primary contact for the Quality Control laboratory, collaborating with staff outside of the department, facilitating timely and right first time data management and reporting, and assuring that manufacturing schedules are met. The supervisor has direct impact on department/group performance through resource management and task scheduling.

The work we do here has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join us and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive. Join us and discover a community that thrives on diversity and never scares away from a complex challenge.

Other duties and responsibilities include, but are not limited to:

• Provides day to day tactical and logistical support for achieving department objectives
• Supervises, coordinates, and assures the testing, review and final release materials in support of batch release
• Assists in the hiring process for department staffing
• Communicates department and personnel expectations and initiates disciplinary action where warranted
• Reviews and approves: data, procedures, and timing in support of batch release
• Anticipates and proactively manages potential problems that affect supply, compliance, and profit plan
• Anticipates and reacts to technical problems, coordinates investigations and develops appropriate solutions; assuring that timelines and milestones are met
• Evaluates and approves deviations / investigation reports
• Collects and evaluates data to ensure that KPl’s are managed to targets.
• Facilitates or coordinates lab validation activities
• Assures staff is fully trained and immediately corrects gaps or deficiencies
• Assures department safety and housekeeping agendas are sustained
• Assures overall laboratory is fit for purpose, compliant, and production ready
• Capable of overseeing, coordinating and ensuring execution of activities and/or projects according to timelines
• Identifies and implements processes for improving time / cost efficiency for allocation of resources
• Conducts performance evaluations and provides constructive feedback to direct reports on an ongoing basis
• Coordinates workflow by scheduling and assigning workloads
• Facilitates development opportunities to direct staff

BACKGROUND REQUIREMENTS:

Minimum Education Requirements

• BS/BA in science, preferably in chemistry, biochemistry, pharmaceutical sciences, or related technical field

Desired Experience

• 5+ years related laboratory experience (4 years required with relevant MS degree)

Specific Skills and Competencies

• Capable of coordinating activities and tasks in a high through-put and high quality, RFT work environment
• Certified or capable of timely certification for Yellow Belt
• Demonstrated subject matter expert in several analytical disciplines
• Proficient technical writing skills
• Able to make informed and timely decisions independently
• Can manage multiple assignments in timely and effective manner
• Effective communication skills with colleagues both within and outside of the department
• Capable of recognizing process gaps and implementing improvements
• Leadership traits that build and foster trust, respect, cooperation, and collaboration across the organization
• Effective listening and coaching skills
• Communicate skills that effectively facilitate project or workflow efficiency and/or distribute information