Pharma Quality Control Technician - Growth & Benefits

Wedgewood Pharmacy LLC; San Jose (CA); Hybrid; USD 36,000 - 50,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Flexible spending accounts

Pet insurance

401(k)

Life and disability insurance

Voluntary insurance options

Paid time off

Growth opportunities

Job summary

Wedgewood Pharmacy LLC in San Jose, CA is seeking a Quality Control Technician to support sterile pharmaceutical manufacturing through release, sampling, environmental monitoring, and batch record review.

You will work Monday through Friday 8:00 am to 4:30 pm, perform trend reporting in Excel, support investigations, and help ensure cGMP compliance and product quality in a fast-paced, team-oriented environment.

Qualifications

• 1+ year of quality experience in a GMP facility.
• High school diploma or equivalent required.
• Experience with sterile injectable products in a pharmaceutical environment preferred; food or cosmetic manufacturing experience will also be considered.

Responsibilities

• Perform day-to-day quality control activities supporting a sterile pharmaceutical manufacturing facility, including material release, sampling and inspection, environmental monitoring, batch record review, and support of investigations and validation activities.
• Release components, containers, closures, packaging, labeling, in-process materials, and finished products.
• Sample and inspect materials and finished products according to SOPs.
• Perform environmental monitoring using aseptic gowning and trend data in Excel or equivalent software; prepare quarterly and annual trend reports.
• Prepare samples for external laboratory analysis and maintain reserve samples.
• Monitor storage conditions for manufacturing areas, materials, and products.
• Review batch production, packaging, labeling, environmental monitoring, microbiological, chemical, and in-process testing records.
• Identify adverse trends and recommend improvements.
• Partner with Production and Shipping/Receiving to ensure materials and supplies are qualified, documented, available, and released.
• Support deviations, non-conforming material, and out-of-specification investigations.
• Support equipment calibration, equipment/utility/facility validation, and preventive maintenance.
• Participate in process performance and product quality reviews and support continual improvement.
• Apply SOPs, forms, cGMP requirements, and operational GMP training to daily quality activities.

Skills

Excel proficiency

Communication

Independent work

Attention to detail

Physical stamina

Education

High school diploma or equivalent

Tools

Microsoft Office

Excel

Job description

Wedgewood Pharmacy LLC in San Jose, CA is seeking a Quality Control Technician to support sterile pharmaceutical manufacturing through release, sampling, environmental monitoring, and batch record review.

You will work Monday through Friday 8:00 am to 4:30 pm, perform trend reporting in Excel, support investigations, and help ensure cGMP compliance and product quality in a fast-paced, team-oriented environment.