Supervisor, Quality Control (Environmental Monitoring) *PC 441

Your Tasks:

The role will be responsible for supervising the daily operations of the Quality Control Analysts as well as to ensure smooth team operations and effective collaboration with each other as well as other areas of the facility. The role will support in scheduling and coordination of the daily Quality Control activities and GMP release testing and facilitating training for QC team members. The role may to a large extent be the first point of contact for Quality Control Analysts across the site.

Essential Duties and Responsibilities:

• Supervise Quality Control (QC) team, oversees the day-to-day activities including review and approval for QC data, and facilitates training for QC team.
• Identify and mitigate risks in QC labs that could negatively impact the safety or quality of the product.
• Responsible for the proper maintenance and use of equipment in strict accordance with cGMPs, SOPs and safety policies.
• Assist with writing and revising Standard Operating Procedures (SOP).
• Prepare protocols or reports for prospective new process/equipment for validation and qualification activities.
• Coordinate the ordering of supplies and proper waste management.
• Lead and perform investigations, as required.
• Coordinate all aspects of incoming samples, sample load, and segregation.
• Coordinate assay qualification and validation activities, as relevant.
• Support career growth and development for QC team.
• Participate and present during scheduled meetings (internal and external), as appropriate.
• Provide cross-functional support to other departments, as required.

Requirements:

• Bachelor’s degree in the life sciences or related concentration from a four-year college or university; Minimum of 5 years working in the biotech industry with demonstrated GMP/GLP experience and 2 years’ experience in a supervisory role; or equivalent combination of education and experience.
• Working knowledge of GMPs and FDA guidance documents
• Must have strong demonstrated experience supporting a QC team.
• Hands on experience with cell culture and aseptic technique is required.

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 is regularly required to walk; use hands to finger, handle, or feel; reach with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature-controlled facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a clean laboratory setting and routinely uses standard equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to viruses. Employees entering the laboratory must wear appropriate clothing and protective equipment such as lab coats, glasses and gloves. The noise level in the work environment is usually moderate.

Miltenyi Biotec is an EO Employer – M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Miltenyi Biotec, Inc. participates in E-Verify.

As a global team of over 3,000 diverse innovators, we are united by a shared vision to advance research and improve patient care worldwide. Our mission transcends mere scientific discovery; we are on a quest to unravel the complexities of biology and transform them into tangible solutions that propel research to unprecedented heights. These developments have led to cutting-edge cell and gene therapies – transformative methods that mobilize the body’s own cells and genetic blueprint to tackle diseases such as cancer and autoimmune conditions. Today, our more than 18,000 solutions play a vital role in paving the way for the medicine of tomorrow. Here, you will contribute to work that is breaking barriers, blending the wonders of biological discovery with the pursuit of well-being for all. Every day presents a chance to make a tangible impact and play a key role in accelerating the journey of research from the lab to the market.