Quality Technician II

Integrated Resources, Inc

Durham, NC

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JOB DETAILS

SKILLS

Air Quality, Assays, Autoclave, Biology, Biotech and Pharmaceutical, Change Control, Chemistry, Corrective Action, Data Entry, Data Management, Distribution Management, Documentation, Environmental Monitoring, Equipment Validation, Inventory Management, Laboratory, Laboratory Analysis, Laboratory Management, Laboratory Testing, Manufacturing, Microbiology, Problem Solving Skills, Procedure Development, Process Improvement, Product Support, Record Keeping, Reporting Skills, Risk Management, Specimens/Samples, Staff Training, Standard Operating Procedures (SOP), Sterilization, Test Lab, Test Plan/Schedule, Testing, Time Management, Workflow Analysis

LOCATION

Durham, NC

POSTED

8 days ago

Job Title: Quality Technician
Location: Durham, NC
Duration: 12 Months (Possible of extension)

Job Description:

The purpose of this position is to conduct standard laboratory tests and routine experiments requiring the use of well-established procedures, with some understanding of related principles.
These tests may be in support of product release, equipment qualification or validation, change control, CAPAs, deviations, process improvements, product transfers or other site initiatives.
Prepares reports and recommends solutions to technical problems as required.
Works on assignments that are moderately complex in nature where judgment is required in resolving problems and making routine decisions. Standard work is conducted with no supervision; new assignments are conducted with general instructions. This position interacts with all functional groups within manufacturing and sterilization, and with other CLS sites, vendors and contract test laboratories.

Product of Work:

Environmental Monitoring: Conduct routine assessments of water, air, and surface quality to identify and mitigate potential contamination risks.

Quality Control Testing:

Perform specified testing of components and finished goods submitted to the laboratory for analysis in a timely manner following the required testing schedule. Reviews test data to ensure results meet all specifications and input data (as applicable).
Perform TOC, Gram staining, Growth promotion, particulate count, bioburden, sterility, endotoxin testing, cell-based assays, and other biological and chemistry testing to verify compliance with quality standards.
Complete investigations and corrective actions as deemed necessary, with a focus on completing testing right the first time.

Sample Management: Manage the sample distribution process, ensuring meticulous tracking and documentation throughout the process.

Inventory Management: Oversee the inventory of laboratory supplies and reagents, including ordering and restocking (as necessary) to support testing activities.

Data Entry and Record-Keeping: Enter test results, observations, and laboratory activities into data management systems accurately and in a timely manner to maintain comprehensive records.
Laboratory Maintenance: Maintain cleanliness and organization in laboratory spaces through routine cleaning procedures, including autoclaving and glassware washing.

Validation / Qualifications:

Perform assay validations, equipment qualifications, or special assignments under general supervision.
Implement and revise standard operating procedures. Identify areas of workflow or procedural inefficiencies and propose solutions to increase efficiency.

Work closely with the Laboratory Supervisor to review technical problems, suggest solutions, and anticipate major problems in key operations.
Use discretion to direct workflow by coordinating laboratory testing assignments and duties.

Train new personnel as per established procedures.
Perform other tasks as assigned.
2–3 years of experience; candidates must have pharma/investigation experience.

Required Education:

Bachelor’s degree in Biology, Microbiology, Chemistry, or a related field.

About the Company

Integrated Resources, Inc

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