Quality Assurance Technician

Ensure and assist with site-specific quality compliance according to Strive Pharmacy Standard operating Procedures (SOPs) & specifications, quality review of documents, label control, assist with release activities and product inspections. 

Key Responsibilities:

• Perform product inspection for defects, leaks and particulates.
• Perform environmental monitoring of sterile production areas and complete documentation.
• Expected to aseptically handle media plates and broth.
• Assist in the media fill process validations to include inspection of filled units.
• Perform documentation review of compounding activities such as cleaning records, line clearance forms and inventory sheets
• 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 noncompliant investigations.
• Support internal & external audits
• Maintain quality records (equipment calibration and maintenance, training, deviation and compliant 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.
• Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.

Preferred 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.
• 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

Work Environment
This position is primarily based in an onsite work environment. The role requires regular periods of sitting, standing, and computer use, with occasional lifting as needed. Reasonable accommodations may be made for individuals with disabilities.