Quality Technician

4 weeks ago

Phoenix, United States Staffmark Group Full time

Advantage Technical is seeking a Quality Technician - Microbiology for our large pharmaceutical client in Phoenix, AZ. This is a 2nd shift position (3:30pm to 12am). This is a great opportunity to gain valuable experience at a fantastic company Do you have what it takes?

Position Summary:

Ensure and assist with site-specific quality compliance according to our client's (SOPs) & specifications, quality review of documents, label control, assist with release activities and product inspections.

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:

o Verify that raw materials meet specification

o Verify and account for labeling

o Review temperature and BMS alarms

o Verify that product test results meet specification limits

o Verify that all documentation is complete

o 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.

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