Quality Control Technician Ii

Role Purpose

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, 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 problem 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.

Key Responsibilities

• 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. Always focusing on completion of 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: Performs assay validations, equipment qualifications or special assignments under general supervision.
• Implements and revises standard operating procedures. Identifies areas of workflow or procedure inefficiencies and proposes solutions to increase efficiency.
• Work closely with the Laboratory Supervisor to review technical problems, suggest solutions and anticipate major problems to key operations.
• Uses discretion to direct workflow by coordinating laboratory testing assignments and duties.
• Trains new personnel as per established procedures

Requirements

• BS degree in the Biological Sciences or equivalent combination of education and related industry experience in GMP environment. An Associates degree in Biological Sciences with 5 plus years industry lab experience could be considered.
• 3+ years of directly related laboratory experience
• The position requires hands on proficiency in microbiological and/or cell-based assay techniques. This includes the ability to detect and remedy minor problems within a cell or microbial assay.
• Requires hands on experience with good aseptic techniques and contamination prevention practices.
• Requires some application of technical principles, practices and procedures. Beginning skills in analytical thinking and problem solving. Seeks technical guidance and educational training to gain technical knowledge in the areas of microbiological or tissue culture testing, environmental and aseptic practices.
• Some knowledge and understanding of pertinent quality system regulations/requirements (i.e. ISO 9001, ISO 11137, ISO 13485, ISO 14644, 21 CFR Part 210/211, Part 820, and cGMP/GLP and USP requirements).
• Ability to work in teams to obtain results by effectively completing assignments with minimal supervision required.
• Ability to work onsite daily