Purpose and Scope of Position
The QC Technician is responsible for supporting Quality Control testing for release of clinical products. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, this position will participate in supporting document management, projects, CAPAs and investigations in accordance with the organizations policies, procedures and state, federal and local laws and compliance with current Good Manufacturing Practices (cGMP), USP, EP, JP and other regulatory requirements at all times.
Required Competencies: Knowledge, Skills, and Abilities
• Hands on experience with various laboratory techniques and environmental monitoring.
• Ability to understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Problem solving ability/mentality, technically adept and logical.
• Ability to work with management locally and globally.
• Follow directions well; work cooperatively as a team leader, an individual contributor and as a team member.
• Advanced written and verbal communication skills.
• Ability to work under limited supervision.
• Communicates effectively with peers, management and cross-functionally across the site.
• Critical reasoning and decision-making skills for solving routine and complex problems that impact multiple departments.
• Ability to deal appropriately with regulatory agencies and act as a Subject Matter Expert (SME) for the department during regulatory and non-regulatory inspections
Duties and Responsibilities
•Collect viable and non-viable samples within controlled environments.
•Collect viable and non-viable samples for compressed gases.
•Collect personnel glove and gown samples.
Participates in aseptic process qualifications:
Documents, Tracks, and Trends test results:
•Record daily data results.
•Prepares spreadsheets of data.
•Trends site specific data.
Education and Experience
• Bachelor’s degree, particularly in a Science related field, required.
• 0-3 years relevant work experience required, preferably in a manufacturing environment with cGMP requirement.
• An equivalent combination of education / experience may substitute.
• The incumbent will be required to wear uniform/ PPE to work in a manufacturing, warehouse, or laboratory environment.
• The incumbent may be fully gowned for extended periods of time within a restrictive movement environment. This may include standing, bending, reaching, kneeling, etc.
• The incumbent will have to perform work in a controlled environment with strict glove and gown requirements.
• The incumbent will be required to maintain a safety alertness due to work around hazardous equipment and cytotoxic product.
• This position requires regular medical surveillance and may require incumbent to wear a respirator or gown.
• The incumbent must be able to distinguish colors and possess correctable vision to 20/20; annual eye exam is required.
• The incumbent may analyze data and work with spreadsheets and graphs on a daily basis.
• The incumbent may be working in a laboratory or manufacturing setting up to 6 hours per day.
• The incumbent must be able to lift/carry NMT 25 lbs.