Lab Tech II - job 1 of 2

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description:
Histology Technician II is responsible for understanding and proficiently performing routine histology technique, while employing good documentation practices (GDPs) in recordkeeping to support Quality Control Product Release Testing. This includes but is not limited to sample receipt and accessioning, initial sample preparation (e.g., rehydration, rinsing, generating labels, etc.), standard grossing and observations, fixation, tissue processing, standard paraffin and cryo-embedding. Depending on skillset and training, may include paraffin and cryo-microtomy. Solution preparation, supply management, maintenance and operation of laboratory equipment, instruments, and workstations is expected. Compliance with standard operating procedures (SOPs), laboratory safety procedures, and maintenance of department databases/files are required. The Histology Technician II is expected to support continuous improvement efforts and the Quality Management System.
Responsibilities:
Technical Support/Sample Preparation:

• Receive, catalogue, and accession specimens.
• Perform Tissue preparation including rehydration of freeze-dried tissue samples; rinsing of "ready to use” tissue samples; record observations and take digital images of gross specimens/test tissue; specimen grossing and fixation/preservation; tissue processing; paraffin embedding; cryo-embedding. May also include paraffin microtomy and/or cryo-microtomy, as assigned.
• Prepare and maintain accurate specimen identification throughout Histology testing process (e.g., specimen containers, cryo vials, cassettes, blocks, slides, images, department data bases, laboratory records and logbooks).
• Operate standard and histology laboratory equipment.
• Comply with cGxP, GDP and SOPs when entering data into workflow spreadsheets, databases, and controlled logbooks.
• Perform block/slide verifications.
• Consistent systematic filing of blocks and slides.  
• Support R&D, Complaints, and Clinical studies as assigned.
• Demonstrate proficient histological technique and recordkeeping to internal/external auditors, management, new and cross-functional employees.

Laboratory Maintenance:

• Prepare stock & working solutions, and label in accordance with chemical management procedures.
• Maintain chemical inventory control and storage requirements.
• Observe universal and safety precautions when handling biological specimens and chemicals. Adhere to waste disposal regulations for chemicals and biohazard materials.
• Maintain a safe laboratory and current SDS file for chemicals.
• Replenish supplies as needed.
• Routine maintenance on laboratory equipment and workstations.
• Keep supervisor/management informed of laboratory operation status.
• Perform troubleshooting, verification checks, and maintenance of instruments and equipment to maximize performance. Tag equipment out-of-service as required; report and schedule service calls when needed.   

Compliance and Continuous Improvement:

• Comply with current Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Adhere to FDA, AATB, OSHA, ISO, and USP standards.
• Observe universal and safety precautions when handling biological specimens and chemicals.
• Participate in safety/chemical programming to ensure compliance with/adherence to local and federal regulations.
• Follow established operating procedures, safety policies, and training requirements.
• Adhere to company work standards and Code of Conduct.
• Participate in 6S audits and support internal and external audits.
• Notify supervisor/management of nonconformances/deviations/safety concerns.
• Support equipment validations.
• Participate in Quality Improvement processes and project as assigned by management to maintain a safe, organized, efficient, and compliant laboratory.

Requirements:

• HS diploma required.
• A.S. in Biology/related science or equivalent work experience.
• 1-3 years Histology laboratory experience.
• GXP lab environment experience preferred.

All your information will be kept confidential according to EEO guidelines.