Spec 1, Quality Control

Katalyst-Healthcares-; El Paso (TX); On-site; USD 45,000 - 65,000; Full time

Job summary

Katalyst-Healthcares- seeks a microbiology lab specialist to support El Paso's Quality Control Laboratory by performing microbiological testing on raw materials, in-process and finished products, and stability samples. Responsibilities include collecting environmental samples, maintaining logbooks per Good Documentation Practices, and assisting with method validations.

Additional duties encompass data trending, equipment maintenance, safety training, and ensuring compliance with QA procedures

Qualifications

• Bachelor's degree in science with emphasis in biology or microbiology.
• 1–3 years of relevant work experience.

Responsibilities

• This position will support El Paso's Quality Control Laboratory by performing microbiological testing on raw materials, in-process product, finished products, and stability samples to achieve QC laboratory deliverables.
• Performs microbiological testing on raw materials, in-process product, finished products, and stability samples according to applicable procedures.
• Collects environmental samples and perform analysis according to applicable site procedures.
• Maintain laboratory trending data.
• Assists in completing project protocols, change notifications, deviation waivers and Quality Notifications with supervision.
• Perform equipment validations/verifications with minimal supervision.
• Execute test method validations as required.
• Performs assigned projects and tasks.
• Compiles testing data and review testing results.
• Maintains Microbiology Laboratory.
• Order supplies, reagents and materials as needed.
• Supports equipment maintenance and calibration activities.
• Understands lab safety and hazardous waste management.
• Cleans and maintains laboratory areas and equipment according to procedures.
• Supports investigations and implementation of corrective actions.
• Responsible for maintaining laboratory logbooks and records according to Good Documentation Practices.
• Performs Microbiology Lab activities as assigned by lab supervisor and/or Quality Manager/Designee in order to achieve QC testing delivery goals.
• Maintains Microbiology Lab audit readiness.

Skills

Microbiology testing

Environmental sampling

Good Documentation Practices

Data trending

Laboratory safety

Equipment maintenance

Education

Bachelor's degree in science with emphasis in biology or microbiology

Job description

Responsibilities:

• This position will support El Paso's Quality Control Laboratory by performing microbiological testing on raw materials, in-process product, finished products, and stability samples to achieve QC laboratory deliverables.


• Performs microbiological testing on raw materials, in-process product, finished products, and stability samples according to applicable procedures.


• Collects environmental samples and perform analysis according to applicable site procedures.


• Maintain laboratory trending data.


• Assists in completing project protocols, change notifications, deviation waivers and Quality Notifications with supervision.


• Perform equipment validations/verifications with minimal supervision.


• Execute test method validations as required.


• Performs assigned projects and tasks.


• Compiles testing data and review testing results.


• Maintains Microbiology Laboratory.


• Order supplies, reagents and materials as needed.


• Supports equipment maintenance and calibration activities.


• Understands lab safety and hazardous waste management.


• Cleans and maintains laboratory areas and equipment according to procedures.


• Supports investigations and implementation of corrective actions.


• Responsible for maintaining laboratory logbooks and records according to Good Documentation Practices.


• Performs Microbiology Lab activities as assigned by lab supervisor and/or Quality Manager/Designee in order to achieve QC testing delivery goals.


• Maintains Microbiology Lab audit readiness.

Education:

• Must have bachelor's in science w/emphasis in Biology or microbiology.


• Work exp - 1-3 years applicable.