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MilliporeSigma · 2 days ago

Manager, Quality Control

St Louis, MO

Full-time

Onsite

Senior Level, Lead/Staff

$134K/yr - $202K/yr

10+ years exp

MilliporeSigma is a global leader in Healthcare, Life Science, and Electronics, seeking a Quality Control Manager to oversee their microbiology department. The role involves managing a team, ensuring compliance with regulations, and driving continuous process improvements in quality control activities.

BiotechnologyMedicalMedical Device

No H1B

Responsibilities

Management and development of Quality Control microbiology department, consisting of 2 groups totaling 20+employees

Accountable to meet business and quality performance metrics through continuous process improvement initiatives

Provide scientific guidance on complex manufacturing investigations and resolution of out-of-specification (OOS) and out-of-trend (OOT) testing results and ensure data integrity

Detect quality problems w/in the department, prepare investigation reports, and implement corrective actions in a timely manner. Manage test deviation as necessary with QA and notify it to management

Collaborate cross functionally as needed to ensure the Quality Management System processes are implemented in accordance with established procedures

Attend project team meetings as the QC microbiology representative and works closely with the team to ensure on-time delivery

Interface with internal and external customers on a regular basis to communicate project status, resolve issues; implement methods, techniques and evaluation criteria for products and processes

Develop and manage the department budget and capital expenditure budget Interact with internal and external customers on regular basis

Participates and supports regulatory/customer audits

Other duties as required

Qualification

GMP Quality ControlMicrobiologyEnvironmental MonitoringMethod ValidationLaboratory Information Management System (LIMS)GMP KnowledgeAseptic PrinciplesLeadershipProblem SolvingCommunication Skills

Required

Bachelor's degree in a scientific discipline or related discipline and/or certification in Quality Management or related area required

10+ years of successful demonstration of the key responsibilities as presented above with in biologics or pharmaceuticals and previous people leadership experience

Demonstrated experience working in a highly matrixed, GMP manufacturing setting

Strong understanding of microbiology (Endotoxin and Bioburden testing); contamination control; Cleanrooms and Aseptic manufacturing; Environmental monitoring etc

Strong understanding of microbiological methodology and laboratory techniques, specifically USP; USP and USP

Knowledge of Laboratory Information Management System (LIMS)