- 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
- 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
- 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.
- 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.
- 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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Quality Technician - Phoenix, United States - Staffmark Group
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Description
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:
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
Expertise:
Knowledge & Skills
Required:
Desired:
After you have applied, download our Staffmark Group WorkNOW App to receive real-time job offers and apply for additional opportunities.