Supervisor, Quality Control *PC Code 638

Your Role:

This position is primarily responsible for the scheduling and coordination of the daily Quality Control activities and GMP release testing. Leading QC team and facilitating training for QC team members.

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.
• Coordinate all aspects of incoming samples, sample load, and segregation.
• Coordinate assay qualification and validation activities.
• Support career growth and development for QC team.
• Participate and present during scheduled meetings (internal and external), as appropriate.
• Lead and perform investigations, as required.
• Provide cross-functional support to other departments, as required.
• Support other aspects of Quality Control, as qualified and necessary.

Requirements:

• Bachelor's (B.S.) or Master's (M.S.) degree in the life sciences or related concentration from a four-year college or university, with a minimum of 5 years of experience working in the biotech industry with demonstrated GMP/GLP experience and 0-2 years' experience in a supervisory role; or equivalent combination of education and experience.
• Must have strong demonstrated experience building and/or leading 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.

The anticipated base salary range has been established at $96,900 - $131,100/year. The hiring range for this position is expected to fall between $96,900 - $114,000/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.

The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.

In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.

Miltenyi Biotec, Inc is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity

Miltenyi Biotec, Inc. participates in E-Verify.

Are you ready to start revolutionizing biomedical research? When you join Miltenyi Biotec, you join a family that is passionate about making a real impact - one breakthrough at a time. One integral division of that Miltenyi Biotec family is Miltenyi Bioindustry - our contract development and manufacturing organization (CDMO). As a full-scale CDMO, we provide customers with services for the development and manufacturing of lentiviral vectors and cell and gene therapy products. This crucial arm of our enterprise bridges the gap between research and mass bioproduction, ensuring that our solutions are accessible on a global scale. Miltenyi Bioindustry plays a unique role as both the producer and the service provider, relying on our instruments and reagents for each workflow step, controlling the entire supply chain and thus delivering greater security and planning clarity to our customers.