Supervisor, Quality Control PC 619 - (Shift: Sunday-Thursday, 1pm-9:30pm) based in San Jose, CA

Miltenyi Biotec•San Jose, CA

2d•Onsite

About The Position

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 management. 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. 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
Must have strong demonstrated experience building and/or leading QC team
Hands on experience with cell culture and aseptic technique is required

Responsibilities

Scheduling and coordination of the daily Quality Control activities and GMP release testing
Leading QC team and facilitating training for QC team members
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
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
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