Pharma Quality Technician - 2nd Shift (Onsite)

RXinsider LTD.; Allentown (Lehigh County); On-site; USD 29,000 - 36,000; Full time

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

Central Admixture Pharmacy in Allentown, PA, is seeking a on-site Quality Inspector for the CAPS network on a 2nd shift to ensure site-specific quality compliance, review SOPs, label control and assist with release activities and product inspections.

You will perform product inspections for defects, monitor environmental conditions, support media fill validations and review documentation to ensure raw materials, labeling and temperatures meet specifications.

Qualifications

• 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.
• Associates degree or higher in Technician, biology, microbiology, chemistry or pharmacy is desirable.

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

Skills

Pharma operations

Calculations

Procedures adherence

Attention to detail

Troubleshooting

Education

High School Diploma or GED

Associate degree or higher (Tech/Science/Pharmacy)

Job description

Central Admixture Pharmacy in Allentown, PA, is seeking a on-site Quality Inspector for the CAPS network on a 2nd shift to ensure site-specific quality compliance, review SOPs, label control and assist with release activities and product inspections.

You will perform product inspections for defects, monitor environmental conditions, support media fill validations and review documentation to ensure raw materials, labeling and temperatures meet specifications.