Quality Control Technician

Essential Duties/Responsibilities:

Perform product inspection for defects, leaks and particulates.

Perform environmental monitoring of personnel (as needed) and complete documentation.

Assist in the media fill process validations to include inspection of filled units

Perform document review of compounding activities such as cleaning records, line clearance forms and inventory sheets:

Verify that raw materials meet specification

Verify and account for labeling

Review temperature and BMS alarms

Verify that product test results meet specification limits

Verify that all documentation is complete

Document non-compliance and work with supervisor/lead if further investigation is needed

Submit samples to the appropriate lab for particulate identification or microbial analysis.

Assist with equipment calibration program and maintenance record files.

Assist with raw material release and movement.

Under the direction of supervisor/lead, document and initiate quality events for deviation and complaint investigations.

Support internal & external audits.

Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).

Participate in Quality Manager’s staff meetings

Expertise: Knowledge & Skills

Knowledge of pharmacy operations and regulatory guidelines.

Ability to perform calculations.

Ability to work within established procedures and practices

Strong organizational skills and attention to detail

Ability to effectively troubleshoot issues.

Required:

Minimum of High School Diploma/GED with work experience

Minimum of 2 years experience in a quality or manufacturing department of a pharmaceutical, Medical Device or Allied Health Science.

Desired:

Experienced in aseptic operations.

Experience within a regulated environment

Associates Degree or higher level degree in Technician technical scientific discipline, Biology, Microbiology, Chemistry or Pharmacy.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 45 pounds.