Quality Technician

JOB SUMMARY

Reporting to the Quality Assurance Manager, Available Shifts - B (2nd) and C (3rd)

ESSENTIAL FUNCTIONS / RESPONSIBILITIES

• Help ensure and assist with site-specific quality compliance according to Standard Operating Procedures (SOPs) & specifications
• Quality review of batch records and other documents
• Label control
• Aid in release activities and product inspections on the production lines
• Lead investigations when deviations occur
• Support routine media fills on the BFS lines
• Complete routine inspections of the production areas
• Part of the internal audit team

QUALIFICATIONS/EXPERIENCE

• High School Diploma/GED required
• Bachelor’s degree in Chemistry, Biology, Pharmacy or related field, preferred
• Must have 2-5 years working in an FDA regulated pharmaceutical or medical device manufacturing environment

PHYSICAL REQUIREMENTS/ENVIRONMENT

• Standing 40% of the time
• Walking 40% of the time
• Sitting 20% of the time
• Able to exert up to 10 pounds of force occasionally
• Works with chemicals, tools, and equipment
• May work in an environment with variable but moderately high noise levels (hearing protection recommended)
• Must wear safety glasses, safety shoes, gloves, and other protective items as required
• Must wear appropriate garments and coverings per cGMP (uniforms, hair/beard nets, etc.)
• Visual acuity necessary to perform activities such as: label inspection, component inspection, and ability to complete detailed review of documents
• The ability to write and communicate information via handwriting, telephone and computer keyboard

SCOPE OF DECISION MAKING

Decisions require basic/routine analytical judgment. Plan and perform diversified duties requiring knowledge of a particular field and the use of a wide range of procedures. Involves the exercise of judgment in the analysis of facts or conditions regarding individual problems or transactions to determine what action should be taken within the guidelines or standard practice.

LEVEL OF SUPERVISION PROVIDED

Individual contributor, not responsible for the work others.

INTERNAL / EXTERNAL CONTACTS

Regular inside and outside: Requires contacts to carry out company policy and programs. Improper handling will have considerable effect on operating results. Must often deal with persons of substantially higher rank on matters requiring explanation, persuasion and obtaining approvals.

COMPENSATION RANGE

Compensation Range 25.00 - 32.00 USD

The referenced compensation range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.